Chi-Med Reports 2017 Interim Results and Updates Shareholders on Key Clinical Programs London: Monday

Chi-Med Reports 2017 Interim Results and Updates Shareholders on Key Clinical Programs

London: Monday, July 31, 2017: Hutchison China MediTech Limited ( Chi-Med ) (AIM/Nasdaq: HCM), the China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market, today announces its unaudited financial results for the six months ended June 30, 2017.

Group: Record revenue; continued investment in clinical pipeline

Innovation Platform: Submitted first China New Drug Application ( NDA ) on fruquintinib; initiated first global Phase III registration study on savolitinib; five other pivotal Phase III studies underway or completing; three more preparing to start

Commercial Platform: High-performance drug marketing and distribution platform covers ~300 cities/towns in China with >3,300 sales people. High value products and household name brands

Solid cash position:

Potential major milestones targeted for rest of 2017 and into 2018

References in this announcement to adjusted research and development expenses, consolidated net income attributable to Chi-Med from our Commercial Platform and consolidated net income attributable to Chi-Med from our Prescription Drugs business are based on non-GAAP financial measures. Please see the Use of Non-GAAP Financial Measures and Reconciliation below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. BST (4:00 p.m. HKT) at Panmure Gordon & Co, One New Change, London EC4M 9AF, U.K.. Investors may participate in the call at +44 20 3003 2666 or access a live video webcast of the call via Chi-Med's website at www.chi-med.com/investors/event-information/.

U.S. Conference Call Scheduled Today at 9:00 a.m. EDT to participate in the call from the United States, please dial 1 866 966 5335.

Additional dial-in numbers are also available at Chi-Med's website. For both calls and all dial-in numbers, please use conference ID Chi-Med.

Simon To, Chairman of Chi-Med, said: Chi-Med's consistent strategy over the past 16 years has generated considerable shareholder value, and we believe it is now poised to deliver substantially more.

In our Innovation Platform, we have progressed our deep portfolio of eight clinical drug candidates, now in 31 active or completing clinical trials around the world. In the process we have achieved two particularly important milestones: the formal NDA submission for fruquintinib in third-line CRC in China; and the initiation of our first global Phase III registration study of savolitinib in c-MET-driven metastatic PRCC. We also presented positive Phase Ib/II data at major scientific conferences in early 2017 on savolitinib in PRCC, fruquintinib in gastric cancer, and sulfatinib in NET and thyroid cancer.

Now, subject to approval, we expect to launch fruquintinib in China in 2018 with our commercial partner, Lilly. Importantly also, later in 2017, we will present eagerly-awaited Phase II clinical trials data on savolitinib in combination with Tagrisso and Iressa in NSCLC thereby allowing AstraZeneca AB (publ) ( AstraZeneca ) to clarify their plans for potential global Phase III registration. Furthermore, we are also now preparing to initiate Phase III registration studies in China of fruquintinib in gastric cancer and of epitinib in NSCLC patients with brain metastasis. The progress of our pipeline is testament to the quality of our in-house research organization, which has discovered all eight of our clinical drug candidates. It also demonstrates that global quality drug discovery is now very much possible in China.

At the same time, regulatory reform is moving at speed in China, improving transparency and raising the standards of clinical data reliability. This helps us, since, at Chi-Med we have always run all our clinical trials to global standards, be they inside or outside China. Fruquintinib is now set to establish an important new reference point, under the reformed regulatory framework in China, for both quality and rigor of clinical trials and for speed to approval. Change is also underway on the National Drug Reimbursement List ( NDRL ) in China, with the first steps having been taken this month to include multiple innovative cancer drugs for some level of reimbursement in a clear move to broaden accessibility.

In parallel, our Commercial Platform continues to grow sales and profits showing resilience against the normal pressures of dynamic and competitive markets. During late 2016 and early 2017, we increased prices in our Prescription Drugs business; and moved our Consumer Health factory over 1,400 kilometers to a lower-cost, larger capacity site in central China. Both had short-term effects; but both are now set to benefit our businesses materially. There were also market pressures on our Consumer Health business, with rapid raw material price increases, a relatively quiet influenza season and around a 5% fall in the Chinese RMB, which affected our U.S. dollar stated financial results. Despite this, net income attributable to Chi-Med from our Commercial Platform increased by 14% to $25.2 million, and we expect to meet full year guidance on core operations. We see this as a measure of the strength of our brands, teams and operations.

Our consistent commercial and scientific strategy, and our pragmatic approach to managing finance and risk, have led to the strength of both our position today and our prospects. The first of our new drug candidates, led by fruquintinib, and including savolitinib, sulfatinib and epitinib, are all progressing towards potential registration and launch in major markets with the balance of our pipeline of drug candidates including theliatinib, HMPL-523, HMPL-689 and HMPL-453 now mostly in proof-of-concept studies.

In addition, our discovery platform is generating a third wave of innovation with a strong focus on immunotherapy. Combining this innovation pipeline with our China marketing and distribution platform, our international partners and our financial stability, all lead Chi-Med to view our future with great confidence.

FINANCIAL HIGHLIGHTS:

Consolidated financial results of the Group are reported under U.S. generally accepted accounting principles ( U.S. GAAP ) and in U.S. dollar currency unless otherwise stated. Chi-Med also conducts its business through three non-consolidated joint ventures, which are accounted for under the equity accounting method as non-consolidated entities in our consolidated financial statements. Within this announcement, certain financial results reported by such non-consolidated joint ventures are referred to, which are based on figures reported in their respective consolidated financial statements prepared pursuant to International Financial Reporting Standards (as issued by the International Accounting Standards Board). Unless otherwise indicated, references to subsidiaries mean the consolidated subsidiaries and joint ventures (excluding non-consolidated joint ventures) of Chi-Med.

Innovation Platform a deep broad, risk-balanced global oncology/immunology pipeline

Commercial Platform a deeply established, cash-generative, pharmaceutical business in China a platform to commercialize our Innovation Platform candidate drugs

KEY H1 2017 OPERATIONAL HIGHLIGHTS:

Innovation Platform: In June this year, we both completed our first NDA submission, for fruquintinib in third-line CRC, and initiated our first global Phase III study in oncology, for savolitinib in PRCC. Each triggered milestone payments from our partners Lilly and AstraZeneca, and each represents major achievements for Chi-Med and for the biotech industry in China.

Hematological cancer: Currently enrolling Phase I dose escalation studies in Australia and China in patients with hematologic malignancies. Dose escalation continues to evaluate both once daily ( QD ) and twice daily regimes and will begin dose expansion with single agent HMPL-523 in due course. We target to present proof-of-concept data in 2018.

Hematological cancer: Completed Phase I study in healthy volunteers in Australia, now preparing to start Phase I in patients with lymphomas in China where we received IND clearance in early 2017.

Esophageal cancer: Phase I dose escalation study is continuing and a Phase II expansion in esophageal cancer patients with a high level of EGFR activation, including gene amplification and protein over-expression was initiated in early 2017.

Solid tumors: During the first half of 2017, we initiated Phase I dose escalation studies in both Australia and China.

Commercial Platform: Net profit increased 14% to $25.2 million (H1 2016: $22.1m) with strong Prescription Drugs growth and $2.5 million in one-time government subsidies more than offsetting the effect of challenging conditions in the OTC business; as well as the -5% weakening of the Chinese RMB.

Short-term OTC profit pressure capacity constraint and depreciation costs caused by regulatory hiatus before the start of production at our new factory; an increase in certain key raw material prices; and the quietest influenza season since 2014.

2017 AND EARLY 2018 MILESTONES: We target to present multiple clinical data updates during the balance of 2017 and early 2018, including:

We hope to achieve multiple clinical and regulatory milestones during 2017 and early 2018, including:

1. Potential NDA approval and launch in third-line CRC in China;

2. Complete enrollment of Phase III FALUCA study in third-line NSCLC;

3. Initiate China Phase III study in second-line gastric cancer;

4. Initiate U.S. Phase I dose confirmation study in Caucasian patients.

1. Initiate China Phase III study in first-line EGFR-mutant NSCLC patients with brain metastasis;

2. Initiate China Phase II study in glioblastoma (primary brain cancer).

FINANCIAL GUIDANCE: Our updated guidance for 2017, compared to the most recent guidance in our full year results announcement for the year ended December 31, 2016 dated March 13, 2017, reflects no overall change to estimated net income/(loss) for the Chi-Med Group. The only adjustment that we would highlight is the potential for deferral, into 2018, of the one-time property gains resulting from Guangzhou government policy. Full year 2017 financial guidance is detailed below:

Notes: [1] Company Guidance March 13, 2017; [2] Attributable to Chi-Med; [3] Joint ventures; [4] timing subject to Guangzhou government policy.

Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited ( CK Hutchison ) (SEHK: 0001). For more information, please visit: www.chi-med.com.

Unless the context requires otherwise, references in this announcement to the Group, the Company, Chi-Med, Chi-Med Group, we, us and our mean Hutchison China MediTech Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like will, expects, anticipates, future, intends, plans, believes, estimates, pipeline, could, potential, believe, first-in-class, best-in-class, designed to, objective, guidance, pursue, or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that Chi-Med obtained from industry publications and reports generated by third-party market research firms, including Frost & Sullivan and QuintilesIMS, independent market research firms, and publicly available data. All patient population, market size and market share estimates are based on Frost & Sullivan or QuintilesIMS research, unless otherwise noted. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med has not independently verified the data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

CHAIRMAN'S STATEMENT

Chi-Med's aim remains to become an innovative global biopharmaceutical company based in China, and we keep making significant progress towards this aim.

Our recent progress in advancing fruquintinib through NDA with the CFDA as well as starting our first global Phase III study in oncology with savolitinib have been particularly important. We are making progress step-by-step on all eight of our clinical drug candidates, and we believe that we are very well positioned to create substantial shareholder value. Our confidence in doing so stems from the following factors.

The inevitability of China oncology In 2016, global market sales of oncology drugs grew by 11% to $175.7 billion making it the largest treatment area in the global pharmaceutical market, with a 17% market share. In China, despite being the home to 8.1 million cancer patients, or about 20-30% of those in the world, 2016 market sales of oncology drugs were just $7.3 billion, or about 4% of the global market. In our view, it is inevitable that the China oncology market is set to emerge over the coming decade as an area of major opportunity, spurred by China's increasing emphasis on innovation combined with its rapidly improving regulatory environment.

Global innovation out of China For sixteen years, Chi-Med and its partners have invested about $480 million in building an engine of global oncology innovation in China. Our approximately 330-person strong scientific team has created, and progressed into development, a portfolio of eight differentiated targeted therapies, primarily in the field of oncology. We have used our fully integrated discovery platform, with its particularly deep competence in chemistry, to create highly selective drug candidates against multiple novel and validated molecular targets, many with the potential to be first-in-class or best-in-class. Global quality innovation, out of China, positions us very well to address the major unmet medical needs in China oncology as well as to identify opportunities for our differentiated assets in the global market.

China regulatory reforms Probably the most exciting development in the context of our ambitions is the transformation that is occurring in the regulatory environment in China. In the clinical and regulatory arena, dozens of policy documents have been published by the State Council and CFDA, aiming to strengthen and speed up China's drug trial and approvals process. These include new standards, supervision and accountability mechanisms that are helping to clear China's drug registration backlog, with the number of applications awaiting CFDA review dropping from 22,000 in 2015 to the current 6,000. Also, the new Priority Review and Market Authorization Holder ("MAH") systems are both clearly helping to speed approval of innovative therapies that meet major unmet medical needs in China.

In the commercial arena, the publication, this month, of the agreed NDRL prices on 36 novel drugs is the first step away from the 100% self-pay system. Many targeted therapies in oncology such as Avastin , Herceptin , Tarceva , Nexavar , Rituxan , Afinitor and Revlimid , among others are now set to be at least partially reimbursed. While prices have been negotiated down to between about one-third and one-half of global prices, both patients and innovative biopharmaceutical companies in China are set to benefit from broadening of access to these important therapies.

Our first wave of innovation is benefiting from regulatory reforms Fruquintinib is the first drug out of the Chi-Med innovation engine to take advantage of the above factors. It has shown that a potential best-in-class asset can be discovered and developed in China. We expect fruquintinib to be granted Priority Review and, upon approval, is likely to be the first MAH designated drug ever to reach the market in China. The interaction with the CFDA in our local region, Shanghai, as well as centrally in Beijing, has been highly collaborative because fruquintinib is a test case for the new system. We hope that time from NDA submission to approval could be rapid and help to establish a new standard. We believe that the balance of our first wave of innovation sulfatinib, epitinib, and theliatinib will also all benefit from these important regulatory reforms.

Our second wave of innovation is on its way Chi-Med's second wave of innovation is focused on more novel, potential first-in-class targets such as c-MET, Syk, and FGFR, as well as a potential best-in-class PI3K inhibitor. All of these programs are in clinical trials and we are moving as fast as we can to reach proof-of-concept in as many indications as possible, looking to build robust data sets that will allow for pivotal trial decisions.

Even greater innovation in the third wave For the past five years, our discovery platform has been working on our third wave of drug candidates, with an emphasis on second-generation immunotherapy targets. The first of these assets should start reaching the clinic in the coming year or so, and we are most excited about the opportunities that will emerge for innovative combination regimes with our first and second wave therapies.

For all these reasons, combined with the financial strength of Chi-Med, the cash being generated by our Commercial Platform and our consistent commercial and scientific strategies, we are highly optimistic about Chi-Med's long-term prospects. As always, the success and prospects of Chi-Med are the result of the commitment and dedication of our people, and I would like to express my deep appreciation to all our management and staff and for the support of the investors, directors and partners of Chi-Med.

Chairman, July 31, 2017

Chi-Med Group revenues for the six months ended June 30, 2017 increased by 21% to $126.6 million (H1 2016: $104.5m), due to a 26% increase in revenue generated by the Commercial Platform to $103.9 million (H1 2016: $82.3m) and our consolidated joint venture, Hutchison Sinopharm. Revenues from our Innovation Platform were flat at $22.7 million (H1 2016: $22.3m), reflecting similar levels of milestone payments, service fees and clinical cost reimbursements received from AstraZeneca, Lilly and NSP compared to the prior period. It should be noted that Group revenues do not include the sales of our two large-scale, 50/50 joint ventures in China, SHPL and Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited ( HBYS ), since these are accounted for using the equity method.

Our Commercial Platform, which for the time being is Chi-Med's primary profit and cash source, grew operating profit by 12% to $27.8 million (H1 2016: $24.9m) as a result of improved profit margins in SHPL's coronary artery disease Prescription Drug business and a one-time Shanghai government subsidy. The Innovation Platform incurred an operating loss of $14.8 million (H1 2016: -$13.8m) as a result of expansion of clinical development activities and investment in the expansion of small molecule manufacturing operations.

Net corporate unallocated expenses, primarily Chi-Med Group overhead and operating costs, increased to $6.7 million (H1 2016: $5.8m) principally due to our Nasdaq listing and the resulting increase in organization and third-party advisor costs in the audit and compliance areas.

Consequently, Chi-Med Group operating profit was $6.3 million (H1 2016: $5.3m).

The aggregate of interest and income tax expenses of the Chi-Med Group, as well as net income attributable to non-controlling interests during the period, was $4.6 million (H1 2016: $4.8m) mainly driven down by reduced share of net income attributable to a non-controlling interest from non-consolidated joint venture under Consumer Health business.

The resulting total Group net income attributable to Chi-Med was therefore $1.7 million (H1 2016: $0.5m).

As a result, Group net income attributable to ordinary shareholders of Chi-Med in the first half of 2017 was $0.03 per ordinary share / $0.015 per American depositary share ( ADS ), compared to a net income attributable to ordinary shareholders of Chi-Med of $0.01 per ordinary share / $0.005 per ADS, in the first half of 2016.

In the past five years, as our clinical spending has escalated, we have endeavored to remain cash-positive at the Chi-Med Group level, and in the first half of 2017, we generated $19.4 million (H1 2016: $9.1m) in net cash from our operating activities. This was driven by significantly increased dividends paid by our non-consolidated Commercial Platform joint ventures which resulted from one-time property compensation and subsidies last year from the Shanghai government as well as growth in the profit of our core operations. These dividends, along with payments received from AstraZeneca, Lilly, and NSP, in their aggregate, more than offset our research and development expenses which were $31.6 million (H1 2016: $31.2m), or $37.5 million (H1 2016: $36.0m) on an as adjusted (non-GAAP) basis.

As of June 30, 2017, we had available cash resources of $192.5 million (December 31, 2016: $173.7m) at the Chi-Med Group level including cash and cash equivalents and short-term investments of $112.5 million (December 31, 2016: $103.7m) and unutilized bank borrowing facilities of $80 million (December 31, 2016: $70m). Aggregate borrowing facilities of $70 million, with an average 18 month term, were renewed in February 2017. In addition, as of June 30, 2017, our non-consolidated joint ventures (SHPL, HBYS and NSP) held $88.8 million (December 31, 2016: $91.0m) in available cash resources.

Outstanding bank loans as of June 30, 2017 amounted to $46.9 million (December 31, 2016: $46.8m) at the Chi-Med Group level, of which $26.9 million is guaranteed by a wholly-owned subsidiary of CK Hutchison, our 60% shareholder. Our total Chi-Med Group weighted average annual interest rate for bank borrowings outstanding as of June 30, 2017 was 1.8% (H1 2016: 1.5%). In addition, we paid a guarantee fee which added about 1.0% to our weighted average annual cost of borrowings in the first half of 2017 (H1 2016: 0.9%). As of June 30, 2017, our non-consolidated joint ventures had no outstanding bank loans (December 31, 2016: nil).

In summary, we believe that the cash resources that we currently hold are sufficient to fund all our near-term activities.

The Chi-Med pipeline of drug candidates has been created and developed by the in-house research and development operation which was started in 2002. Since then, we have assembled a large team of about 330 scientists and staff based in China and operating a fully-integrated drug discovery and development operation covering chemistry, biology, pharmacology, toxicology, chemistry and manufacturing controls for clinical and commercial supply, clinical and regulatory and other functions. Looking ahead, we plan to continue to leverage this platform, as we had in the past decade, to produce a stream of novel drug candidates with global potential.

Since inception, the Innovation Platform has dosed over 3,100 patients/subjects in clinical trials of our drug candidates with over 300 dosed in the first half of 2017 primarily driven by the enrollment of the Phase III studies that we currently have underway.

Product Pipeline Progress

Savolitinib (AZD6094): Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. We designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 500 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in PRCC, NSCLC, CRC and gastric cancer with an acceptable safety profile.

We are currently testing savolitinib in partnership with AstraZeneca in multiple Phase Ib/II studies, both as a monotherapy and in combination with other targeted therapies, and in June 2017, we initiated our first global Phase III registration study in PRCC. Later in 2017, we plan to present Phase II data at a major scientific conference on savolitinib in combination with Tagrisso and Iressa , in both second- and third-line NSCLC.

Savolitinib Kidney cancer: High proportion of MET-driven patients.

Study 1 Enrolling Phase III PRCC savolitinib 600mg QD monotherapy (Global) PRCC is the most common of the non-clear cell renal cell carcinomas ( RCCs ) representing about 14% of kidney cancer. Approximately 366,000 new cases of kidney cancer were diagnosed globally in 2015, equating to about 50,000 cases of PRCC, with approximately half harboring c-MET-driven disease. No systemic therapies/TKIs have been approved in PRCC, and to date only modest efficacy in non-ccRCC has been reported in sub-group analyses of broader RCC studies of VEGFR (e.g. Sutent ) and mammalian target of rapamycin (mTOR) (e.g. Afinitor ) TKIs, with ORRs of <10% and median PFS in first-line setting of 4-6 months and second-line setting of only 1-3 months (ESPN study, Tannir N. M. et al.).

During the first half of 2017, we presented the results of our 109 patient global Phase II study in PRCC at the ASCO Genitourinary Cancers Symposium, as well as in the Journal of Clinical Oncology as a Rapid Communication Manuscript. This Phase II study was the largest and most comprehensive clinical study in PRCC ever conducted. Of 109 patients treated with savolitinib, PRCC was c-MET-driven in 44 patients (40%), c-MET-independent in 46 (42%) and MET status unknown in 19 (17%). c-MET-driven PRCC was strongly associated with encouragingly durable response to savolitinib with ORR in the c-MET-driven group of 18.2% (8/44) as compared to 0% (0/46) in the c-MET-independent group (p=0.002). Median PFS for patients with c-MET-driven and c-MET-independent PRCC was 6.2 months (95% CI: 4.1 7.0) and 1.4 months (95% CI: 1.4 2.7), respectively (hazard ratio=0.33; 95% CI: 0.20 0.52; log-rank p<0.0001). Savolitinib was well tolerated, with no reported treatment related Grade 3 AEs with >5% incidence. Total aggregate savolitinib treatment related Grade 3 AEs occurred in just 19% of patients comparing very well to the 70-75% Grade 3 AE level recorded in VEGFR inhibitors such as Sutent and Votrient (pazopanib) in multiple RCC studies (N Eng J Med 369;8, R J Motzer et al).

A global Phase III registration study, the SAVOIR study, of savolitinib versus Sutent in c-MET-driven metastatic PRCC patients was initiated in June 2017 and expects to enroll 180 patients. The primary endpoint for efficacy in the SAVOIR study is median PFS, with secondary endpoints of OS, ORR, Duration of Response ( DoR ) and DCR. We expect to complete enrollment in late 2019.

Study 2 Enrolling Phase II study of multiple TKIs in metastatic PRCC (U.S.) A Phase II study, sponsored by the U.S. National Cancer Institute, and named the PAPMET study, to assess the efficacy of multiple TKIs in metastatic PRCC including Sutent ; Cabometyx (cabozantinib); Xalkori (crizotinib) and savolitinib. PAPMET, began enrolling patients in 2016 and had registered 26 patients by January 2017. PAPMET is expected to enroll about 275 patients in over 70 locations in the United States with top line data targeted for reporting in 2019.

Study 3, Study 4 and Study 5 Enrolling Phase Ib study of savolitinib (600mg daily) monotherapy and in combination with Imfinzi (anti-PD-L1) in both PRCC and ccRCC patients (U.K.) A Phase Ib dose finding study began in 2016, named the CALYPSO study, at St. Bartholomew's Hospital in London, to assess safety/tolerability of savolitinib and Imfinzi combination therapy as well as preliminary efficacy of savolitinib as a monotherapy or combination therapy in several c-MET-driven kidney cancer patient populations. During 2016, the dose-finding section of the CALYPSO study successfully established the combination dose of savolitinib and Imfinzi and the study has now moved on to the expansion stage in ccRCC patients to further explore efficacy.

Savolitinib Lung cancer: Savolitinib's largest market opportunity.

Study 6 Enrolling Phase II expansion NSCLC (second-line), EGFR TKI refractory, savolitinib (600mg QD) in combination with Tagrisso (Global) In October 2016, at the European Society for Medical Oncology meeting, AstraZeneca presented preliminary Phase Ib/IIa data, the TATTON study (Part A), on 17 evaluable first-generation EGFR TKI (Iressa /Tarceva ) refractory second-line NSCLC patients who had no prior exposure to third-generation EGFR TKIs (Tagrisso /rocelitinib). Molecular analysis of both c-MET and T790M status was completed for patients with sufficient available tumor tissue. Of patients treated with the savolitinib and Tagrisso combination, confirmed PRs were reported in 4/5 (80% ORR) of c-MET positive/T790M negative patients and in 6/10 (60% ORR) of c-MET positive patients regardless of T790M status.

In June 2016, we initiated a global Phase II expansion study in second-line NSCLC, the TATTON study (Part B), aiming to recruit sufficient c-MET positive patients to support a decision on whether or not to proceed to global Phase III registration studies. We believe that we are on-track to meet this aim and expect to present preliminary TATTON (Part B) data at a major scientific conference later in 2017. We hope that if the ORR and DoR data from TATTON (Part B) meets the requirements, we would consider seeking potential U.S. Food and Drug Administration ( FDA ) Breakthrough Therapy designation in parallel with Phase III initiation. In this second-line EGFR TKI refractory NSCLC population, c-MET-driven disease exists in 15-20% of patients or approximately 35,000-40,000 new patients per year globally.

Study 7 Enrolling Phase II NSCLC (third-line), EGFR/T790M TKI-refractory, savolitinib (600mg QD) in combination with Tagrisso (Global) The TATTON study (Part B) is also enrolling third-line NSCLC patients that have progressed after treatment with Tagrisso in the second-line setting as a result of c-MET-driven acquired resistance. Data presented in June 2017 at ASCO, by Harvard Medical School and Massachusetts General Hospital Cancer Center, showed that about 30% (7/23 patients) of Tagrisso resistant third-line NSCLC patients harbor c-MET gene amplification. Furthermore, in the three Tagrisso resistant, c-MET gene amplified, third-line NSCLC patients that were then exposed to savolitinib, all three were reported to have confirmed PRs. We also intend to present preliminary TATTON (Part B) data in this third-line NSCLC population at a major scientific conference later in 2017. Tagrisso sales in the first half of 2017, just over 18 months since its launch, were $403 million, indicating that the market potential for savolitinib in third-line, Tagrisso resistant, NSCLC is material.

Study 8 Enrolling Phase II NSCLC (second-line), EGFR TKI-refractory, savolitinib (600mg QD) in combination with Iressa (China) In the subset of EGFR-TKI refractory second-line NSCLC patients, who are c-MET positive but do not harbor T790M mutation, a combination regimen of savolitinib and Iressa could be appropriate. In late 2015, we began a Phase II study comprised of a dose-finding stage, to establish a safe combination dose of savolitinib and Iressa , followed by an expansion stage to enroll sufficient patients in order to support a decision on whether or not to proceed to a Phase III registration study of the combination. We intend to present the complete results of this Phase II study at a major scientific conference later in 2017. The launch of multiple lower-priced, and reimbursed, generic first-generation EGFR TKIs in China this year, combined with the very high ~50% proportion of NSCLC patients who harbor the EGFR activating mutation, leads us to believe there may be a surge in c-MET positive second-line NSCLC patients in China over the coming years that could total approximately 20,000 new patients per year.

Study 9 and Study 10 Enrolling Phase II c-MET-driven NSCLC (first-line) savolitinib (600mg QD) monotherapy (China) Phase II studies of savolitinib are also ongoing in first-line NSCLC and other lung cancer patient populations, focusing on those with c-MET-driven disease.

Savolitinib Gastric cancer: Multiple active exploratory Phase Ib gastric cancer clinical studies are ongoing in China and a multi-arm Phase Ib study, named the VIKTORY study, being run at Samsung Medical Center in South Korea. As of January 2017, a total of 432 metastatic gastric cancer patients had been enrolled in VIKTORY with 5.3% (23/432) being patients with c-MET-driven (gene amplification or over-expression) disease, which is consistent with prior scientific publications. These patients with c-MET-driven disease are being guided to the following three studies:

Study 11 Enrolling Phase Ib gastric cancer, savolitinib monotherapy, patients with c-MET gene amplification (South Korea/China) Phase Ib study of savolitinib is ongoing, and to date we have observed preliminary efficacy in gastric cancer patients that harbor c-MET gene amplification.

Study 12 and Study 13 Enrolling Phase Ib studies of savolitinib (600mg QD) in combination with Taxotere in c-MET over-expression or c-MET gene amplification gastric cancer (South Korea) Phase Ib dose finding studies are underway to assess safety/tolerability of savolitinib and Taxotere combination as well as preliminary efficacy of the savolitinib monotherapy and combination therapy in the approximately 40% of gastric cancer patients harboring c-MET over-expression.

Fruquintinib (HMPL-013): Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3 that was designed to be, and we believe has now been shown to be, a best-in-class VEGFR inhibitor for solid tumors. Fruquintinib's unique kinase selectivity has been shown to reduce off-target toxicity, in particular hepatotoxicity (liver toxicity), thereby allowing for better target coverage at the recommended dose, and allows for possible use in combination with other targeted or immunotherapy agents and chemotherapy. We believe these are points of meaningful differentiation compared to other approved small molecule VEGFR inhibitors, such as Sutent , Nexavar (sorafenib) and Stivarga (regorafenib). In addition to the FRESCO study in third-line CRC in China, we are also enrolling FALUCA, a pivotal Phase III study of fruquintinib in third-line NSCLC, and are in final planning of a Phase III study of fruquintinib in combination with Taxol in the second-line setting for gastric cancer. Furthermore, a Phase II study of fruquintinib in combination with Iressa in first-line EGFR-mutant NSCLC began in early 2017 and a Phase I study of fruquintinib in the United States is set to start this year.

Study 14 NDA submitted June 2017 Phase III study in CRC (third-line or above), fruquintinib monotherapy (China) The FRESCO study, is a pivotal Phase III study in 416 patients with locally advanced or metastatic CRC disease that progressed following at least two prior systemic chemotherapies. Patients were randomized in a 2:1 ratio to receive either 5mg of fruquintinib QD orally, on a 3 weeks on/1 week off cycle, plus best supportive care or placebo plus best supportive care. The primary endpoint of median OS was 9.30 months [95% CI: 8.18 10.45] in the fruquintinib group vs. 6.57 months [95% CI: 5.88 8.11] in the placebo group, with a hazard ratio of 0.65 [95% CI: 0.51 0.83; two-sided p<0.001]. The secondary endpoint of median PFS was 3.71 months [95% CI: 3.65 4.63] in the fruquintinib group vs. 1.84 months [95% CI: 1.81 1.84] in the placebo group, with a hazard ratio of 0.26 [95% CI: 0.21 0.34; two-sided p<0.001]. Significant benefits were also seen in other secondary endpoints. The fruquintinib group DCR was 62.2% vs. 12.3% for placebo (p<0.001), while the ORR was 4.7% vs. 0% for placebo (p=0.012).

In terms of safety, results showed that fruquintinib had a manageable safety profile with lower off-target toxicities compared to other targeted therapies, and did not demonstrate the sometimes severe and fatal hepatotoxicity observed with other therapies in this disease setting. The most frequently reported fruquintinib-related grade 3 AEs included hypertension (21.2%), hand-foot skin reaction (10.8%), proteinuria (3.2%) and diarrhea (2.9%), all associated with VEGFR inhibition. No other grade 3 AEs exceeded 1.4% in the fruquintinib population, including hepatic function AEs such as elevations in bilirubin (1.4%), alanine aminotransferase (ALT) (0.7%) or aspartate aminotransferase (AST) (0.4%). In terms of tolerability, dose interruptions or reductions occurred in only 35.3% and 24.1% of patients in the fruquintinib arm, respectively, a far lower level than other small molecule VEGFR TKIs, and only 15.1% of patients discontinued treatment of fruquintinib due to intolerable toxicities vs. 5.8% for placebo.

We completed submission of the NDA to the CFDA in early June 2017, approximately two months after receiving the full FRESCO data set in late March. Subject to approvals, we expect fruquintinib will launch in China in 2018 thereby benefiting a conservative estimation of 50,000-60,000 new third-line CRC patients per year across China and currently without a standard therapy. We believe that fruquintinib in third-line CRC has approximately $110-160 million peak sales potential, and this could equate to about $20-35 million in incremental net income to Chi-Med. The basis of these estimates are Phase II level median PFS; wholesaler acquisition cost similar to that of TKIs in China; the above estimated incidence of third-line CRC; and estimated eventual penetration to 20-25% of these patients.

Study 15 Enrolling Phase III NSCLC third-line fruquintinib monotherapy (China) In December 2016, at the World Conference on Lung Cancer ( WCLC ), we presented positive Phase II results in third-line NSCLC patients, which showed median PFS of 3.8 months for the fruquintinib group compared to 1.1 months for the placebo group (hazard ratio=0.27, p<0.001); an ORR of 16.4% for the fruquintinib group compared to 0% for the placebo group (p=0.02); a DCR of the fruquintinib group significantly higher than that of the placebo group with a difference of 53.8% (36.3, 71.4; 95% CI, p<0.001). Fruquintinib was well tolerated with the only treatment related Grade 3 AEs, with >5% incidence, being hypertension (8.2%). In December 2015, we initiated the FALUCA study in China, which is a pivotal Phase III study in advanced non-squamous NSCLC patients who had disease progression following two prior systemic chemotherapies. Patients are randomized in a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a 3 weeks on/1 week off cycle plus best supportive care, or placebo plus best supportive care. The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and DoR. We expect to complete FALUCA enrollment in early 2018 and report top-line results when we reach OS maturity in late 2018.

Study 16 Enrolling Phase II study of fruquintinib in combination with Iressa in first-line NSCLC (China) In January 2017, we initiated a multi-center, single-arm, open-label Phase II study of fruquintinib in combination with Iressa in the first-line setting for patients with advanced or metastatic NSCLC with EGFR activating mutations. The objectives of the Phase II study are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy.

Study 17 Planning Phase I fruquintinib monotherapy in advanced solid tumors (U.S.) Our U.S. FDA IND application for fruquintinib was cleared in late 2016. A Phase I study in Caucasian cancer patients is now set to begin in the United States in 2017.

Study 18 Completed (now progressing to Phase III) Phase Ib study of fruquintinib in combination with Taxol in gastric cancer (second-line) (China) In early 2017, at the ASCO Gastrointestinal Cancers Symposium, we presented results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with Taxol in second-line gastric cancer. A total of 32 patients were enrolled in the study and 28 of 32 patients were efficacy evaluable with an ORR of 36% and a DCR of 68%. At fruquintinib recommended Phase II dose ( RP2D ), 16 week PFS was 50% and 7 month OS was 50%. Tolerability of the RP2D combination was as expected with common treatment related Grade 3 AEs being neutropenia (41%), leukopenia (28%), decreased hemoglobin (6%), and hand-foot syndrome (6%). Based on Phase Ib data, we plan to move directly into a Phase III registration trial in China in 2017.

Sulfatinib (HMPL-012): Sulfatinib is an oral drug candidate with a unique angio-immuno kinase profile which provides both anti-angiogenesis effect and, we believe, activates and effectively enhances the body's immune system, specifically T-cells. Importantly, in 2016 we presented pre-clinical data for the first time that show sulfatinib, in addition to inhibiting VEGFR and FGFR1, is a potent inhibitor of CSF-1R, a signaling pathway involved in blocking the activation of tumor-associated macrophages, which cloak cancer cells from attack from T-cells. Our Phase I clinical data in 21 NET patients reported strong efficacy in terms of ORR (>30%) and PFS (>18 months) across a broad spectrum of NET sub-types. These Phase I data compared favorably to the less than 10% ORR and 11.4 month median PFS for Sutent and Afinitor , the two approved single agent therapies for pancreatic NET. Sulfatinib is the first oncology candidate that we have taken through proof-of-concept in China and subsequently started clinical development in the United States. We are currently conducting six clinical studies and retain all rights to sulfatinib worldwide.