Full Press Release Details
HUTCHMED Reports 2024 Interim Results and Provides Business Updates
Hong Kong, Shanghai & Florham Park, NJ - Wednesday, July 31, 2024: HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2024 and provides updates on key clinical and commercial developments.
HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, August 1, 2024. After registration, investors may access the live webcast via HUTCHMED's website at www.hutch-med.com/event.
All amounts are expressed in US dollars unless otherwise stated.
Continued revenue momentum with substantial cash balance to support growth
Globalization of fruquintinib continues, broader pipeline makes strong progress
Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "HUTCHMED has delivered strong performance in the first half of this year. The team has made significant progress implementing our strategy in discovering and developing novel, effective medicines; conducting clinical trials in our home market and in the global markets; and rapidly advancing regulatory and commercial goals. I am very pleased with the ongoing success of our partnership with Takeda and with the growing ability of the Company to provide health benefits to patients overseas. We have grown our revenues from the US during this period and we expect to see revenue growth from many other countries in the coming months. We are also capitalizing on our proven track record of bringing new medicines and additional indications for our marketed medicines to China, with several potential NDA approvals for the next few years."
"I would like to take this opportunity to express my appreciation to Mr Simon To, my predecessor, who has recently retired. Mr To has stood at the cradle of HUTCHMED and has made a very significant contribution to grow the Company and turn it into a global innovative player, discovering, developing and commercializing therapies for the treatment of cancer and immunological diseases, improving the quality of life of patients around the world. I look forward to guiding the Company along its next phase of growth, which is full of potential and promise."
2024 INTERIM RESULTS & BUSINESS UPDATES
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "The HUTCHMED team has been working tirelessly to continue the outstanding clinical and regulatory momentum that we have had in recent years, whilst importantly driving the commercial success of our approved products. I would like to extend my thanks to everyone for their hard work and commitment. Our oncology product revenue has grown 59% compared to the first half of 2023 and we are progressing a more focused R&D pipeline that has considerable potential for value creation. This year we initiated three key late-stage studies across our pipeline and are excited to be running over a dozen such studies that could support future drug approvals."
"The partnership strategy that we adopted for globalizing our medicines is allowing us to simultaneously fuel our in-house R&D engine, drive sales in our home market, and bring our medicines to patients in new geographies. Takeda's impressive initial sales of FRUZAQLA demonstrates both the quality of our medicines and their potential across the globe and our strategy of working with partners outside of our home market."
"We expect to advance our registration trials in the second half of the year. Around year end, we anticipate the potential approval of sovleplenib in China and potential NDA filing of savolitinib in the US. We will continue to progress towards becoming a self-sustaining biopharma business."
I. COMMERCIAL OPERATIONS
Oncology in-market sales were up 140% (145% at CER) to $243.3 million (H1-23: $101.3m), which led to strong growth in consolidated oncology product revenue of 59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly comprised of the following:
Oncology/Immunology consolidated revenue comprised of consolidated oncology product revenue, which included product revenue, commercial service fees and royalties, as well as R&D income from our collaboration partners, mainly as follows:
As a result, total Oncology/Immunology consolidated revenue was $168.7 million (H1-23: $359.2m). Including Other Ventures revenue, total revenue was $305.7 million (H1-23: $532.9m).
| (Unaudited, $ in millions) | In-market Sales* | Consolidated Revenue** | ||||||||||||||||||
| H1 2024 | H1 2023 | % | (CER) | H1 2024 | H1 2023 | % | (CER) | |||||||||||||
| FRUZAQLA | $ | 130.5 | - | - | $ | 42.8 | - | - | ||||||||||||
| ELUNATE | $ | 61.0 | $ | 56.3 | +8% | (+13%) | $ | 46.0 | $ | 42.0 | +9% | (+14%) | ||||||||
| SULANDA | $ | 25.4 | $ | 22.6 | +12% | (+17%) | $ | 25.4 | $ | 22.6 | +12% | (+17%) | ||||||||
| ORPATHYS | $ | 25.9 | $ | 22.0 | +18% | (+22%) | $ | 13.1 | $ | 15.1 | -14% | (-10%) | ||||||||
| TAZVERIK | $ | 0.5 | $ | 0.4 | +40% | (+46%) | $ | 0.5 | $ | 0.4 | +40% | (+46%) | ||||||||
| Oncology Products | $ | 243.3 | $ | 101.3 | +140% | (+145%) | $ | 127.8 | $ | 80.1 | +59% | (+64%) | ||||||||
| Takeda upfront, milestone and R&D services | $ | 33.8 | $ | 269.1 | -87% | (-87%) | ||||||||||||||
| Other R&D services | $ | 7.1 | $ | 10.0 | -29% | (-27%) | ||||||||||||||
| Total Oncology/Immunology | $ | 168.7 | $ | 359.2 | -53% | (-52%) | ||||||||||||||
| Other Ventures | $ | 137.0 | $ | 173.7 | -21% | (-18%) | ||||||||||||||
| Total Revenue | $ | 305.7 | $ | 532.9 | -43% | (-41%) |
* = For FRUZAQLA , ELUNATE and ORPATHYS , mainly represented total sales to third parties as provided by Takeda, Lilly18 and AstraZeneca, respectively.
** = For FRUZAQLA , represented drug product supply and royalties paid by Takeda; for ELUNATE , represented drug product supply, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS , represented drug product supply and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA and TAZVERIK , represented the Company's sales of the products to third parties.
II. REGULATORY UPDATES
III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET23
Potential upcoming clinical and regulatory milestones for savolitinib:
Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity
Potential upcoming clinical and regulatory milestones for fruquintinib:
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathways
Potential upcoming clinical milestones for sovleplenib:
Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR40 and CSF-1R41 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation
Tazemetostat (TAZVERIK in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2
HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
HMPL-306, an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes, which have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors
Other early-stage investigational drug candidates
IV. COLLABORATION UPDATES
Further clinical progress by Inmagene46 with two candidates discovered by HUTCHMED
HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In April 2024, we published our 2023 Sustainability Report, which highlighted progress made in our 11 goals and targets; our enhanced climate actions including Scope 3 emissions screening and measurement and engaging with suppliers; our enhanced data quality; our strengthened alignment of our five most relevant and material sustainability pillars; and our enhanced disclosure and sector specific disclosure standards ahead of requirement.
Wider recognition of HUTCHMED's e orts have been reflected in steady improvements in major local and international sustainability ratings including from Hang Seng, ISS, MSCI, S&P Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for S&P Global ESG48 Ratings, significantly higher than the industry average of 31. HUTCHMED also received the Best ESG(E) at the Hong Kong Investor Relations Association's 10th Investor Relations Awards, two awards at Bloomberg Businessweek's ESG Leading Enterprises event, five awards from Metro Finance's GBA ESG Achievement Awards, and was listed amongst the Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness by Healthcare Executive.
In 2024, we continue our efforts on the above areas and further strengthening our climate action by conducting a more comprehensive climate risk assessment to quantify the impact of climate risks in our major operations; incorporate sustainability into our corporate culture; and considering future goals and targets.
FINANCIAL HIGHLIGHTS
Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 4% during the first half of 2024, which has impacted our consolidated financial results as highlighted below.
Cash, Cash Equivalents and Short-Term Investments were $802.5 million as of June 30, 2024 compared to $886.3 million as of December 31, 2023.
Revenue for the six months ended June 30, 2024 was $305.7 million compared to $532.9 million in the six months ended June 30, 2023.
Net Expenses for the six months ended June 30, 2024 were $279.9 million compared to $364.3 million in the six months ended June 30, 2023, reflecting our strong efforts on cost control.
Net Income attributable to HUTCHMED for the six months ended June 30, 2024 was $25.8 million compared to $168.6 million for the six months ended June 30, 2023.
We reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED's work in 2024 and beyond will be supported by its strong balance sheet. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide.
Shareholders and investors should note that:
Use of Non-GAAP Financial Measures and Reconciliation - References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
Condensed Consolidated Balance Sheets Data
| (in $'000) | As of | As of | ||
| June 30, 2024 | December 31, 2023 | |||
| (Unaudited) | ||||
| Assets | ||||
| Cash and cash equivalents and short-term investments | 802,453 | 886,336 | ||
| Accounts receivable | 156,916 | 116,894 | ||
| Other current assets | 88,891 | 93,609 | ||
| Property, plant and equipment | 94,815 | 99,727 | ||
| Investment in an equity investee | 80,519 | 48,411 | ||
| Other non-current assets | 37,274 | 34,796 | ||
| Total assets | 1,260,868 | 1,279,773 | ||
| Liabilities and shareholders ' equity | ||||
| Accounts payable | 43,398 | 36,327 | ||
| Other payables, accruals and advance receipts | 249,218 | 271,399 | ||
| Deferred revenue | 108,777 | 127,119 | ||
| Bank borrowings | 82,100 | 79,344 | ||
| Other liabilities | 25,357 | 22,197 | ||
| Total liabilities | 508,850 | 536,386 | ||
| Company ' s shareholders ' equity | 740,084 | 730,541 | ||
| Non-controlling interests | 11,934 | 12,846 | ||
| Total liabilities and shareholders ' equity | 1,260,868 | 1,279,773 |
Condensed Consolidated Statements of Operations Data
| (Unaudited, in $'000, except share and per share data) | Six months ended June 30, | |||
| 2024 | 2023 | |||
| Revenue: | ||||
| Oncology/Immunology - Marketed Products | 127,796 | 80,149 | ||
| Oncology/Immunology - R&D | 40,841 | 279,034 | ||
| Oncology/Immunology consolidated revenue | 168,637 | 359,183 | ||
| Other Ventures | 137,044 | 173,691 | ||
| Total revenue | 305,681 | 532,874 | ||
| Operating expenses: | ||||
| Cost of revenue | (180,135) | (208,324) | ||
| Research and development expenses | (95,256) | (144,633) | ||
| Selling and administrative expenses | (57,811) | (68,263) | ||
| Total operating expenses | (333,202) | (421,220) | ||
| (27,521) | 111,654 | |||
| Other income, net | 22,765 | 25,434 | ||
| (Loss)/income before income taxes and equity in earnings of an equity investee | (4,756) | 137,088 | ||
| Income tax expense | (2,886) | (2,730) | ||
| Equity in earnings of an equity investee, net of tax | 33,807 | 35,110 | ||
| Net income | 26,165 | 169,468 | ||
| Less: Net income attributable to non-controlling interests | (364) | (917) | ||
| Net income attributable to HUTCHMED | 25,801 | 168,551 | ||
| Earnings per share attributable to HUTCHMED (US$ per share) | ||||
| - basic | 0.03 | 0.20 | ||
| - diluted | 0.03 | 0.19 | ||
| Number of shares used in per share calculation | ||||
| - basic | 856,030,704 | 846,928,863 | ||
| - diluted | 872,534,466 | 866,990,610 | ||
| Earnings per ADS attributable to HUTCHMED (US$ per ADS) | ||||
| - basic | 0.15 | 1.00 | ||
| - diluted | 0.15 | 0.97 | ||
| Number of ADSs used in per share calculation | ||||
| - basic | 171,206,141 | 169,385,773 | ||
| - diluted | 174,506,893 | 173,398,122 |
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com | |
| Media Enquiries | ||
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com | |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com | |
| Nominated Advisor | ||
| Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum | +44 (20) 7886 2500 |
Unless the context requires otherwise, references in this announcement to the "Group," the "Company," "HUTCHMED," "HUTCHMED Group," "we," "us," and "our," mean HUTCHMED (China) Limited and its subsidiaries 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 US 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," "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, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, "HUTCHMED's Products") 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, including, among others, the risk that HUTCHMED's ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; 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 the utilization, market acceptance and commercial success of HUTCHMED's Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED's Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED's Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED's Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED's Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; 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, uncertainties regarding future global exchange rates and uncertainties regarding the impact of pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, on AIM and on HKEX53. HUTCHMED 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 HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this 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 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
We discover, develop, manufacture and market targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 890 scientists and staff, and an in-house oncology commercial organization of approximately 930 staff.
We have 13 oncology drug candidates in clinical trials. Three of our medicines, fruquintinib, surufatinib and savolitinib, have all been approved and launched in mainland China with fruquintinib also approved in the US, EU, Hong Kong and Macau. Our fourth medicine, tazemetostat, has been approved and launched in Hainan Pilot Zone, Hong Kong and Macau.
MARKETED PRODUCT SALES
In-market sales of HUTCHMED's novel oncology products grew 140% (145% at CER) to $243.3 million (H1-23: $101.3m) in the first half of 2024, predominantly from the launch of FRUZAQLA . Despite continuing impact from regulatory challenges in China from the third quarter of 2023 onwards, China in-market sales grew 11% (16% at CER) to $112.8 million.
Fruquintinib (FRUZAQLA outside of China, ELUNATE in China)
CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer/World Health Organization, CRC is the third most prevalent cancer worldwide, associated with more than 1.9 million new cases and 900,000 deaths in 2022. In particular, it estimates China, the US, Europe and Japan had approximately 517,000; 153,000; 538,000 and 146,000 new cases in 2022, making it the first or second most common cancer in each region. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.
FRUZAQLA was launched by Takeda in the US within 48 hours after it was approved for previously-treated metastatic CRC on November 8, 2023, with the first prescription received a day after approval. According to Takeda, uptake has been strong, exceeding expectations. FRUZAQLA was also approved in the EU on June 20, 2024 following a positive opinion from the Committee for Medicinal Products for Human Use on April 25, 2024. Additional regulatory applications progressing as expected in over a dozen other jurisdictions. In the first half of 2024, FRUZAQLA achieved in-market US sales of $130.5 million (H1-23: nil).
This US patient uptake was in parallel to the rapid inclusion of fruquintinib to the 2023 "NCCN Clinical Practice Guidelines for Colon Cancer" and the 2023 "NCCN Clinical Practice Guidelines for Rectal Cancer" on November 16, 2023. Fruquintinib has also been successfully recommended in several other major treatment guidelines for colorectal cancer. These will continue to drive awareness and usage of fruquintinib among doctors and patients.
ELUNATE in China achieved in-market sales of $61.0 million in the first half of 2024, up 8% (13% at CER) versus the first half of 2023 ($56.3m). In China, ELUNATE is the leading treatment for late-stage CRC with 47% of third-line treated patient share according to an IQVIA tracking study in the second quarter of 2024.
Under the terms of our agreement with Lilly, HUTCHMED manages all on-the-ground medical detailing, promotion and local and regional marketing activities for ELUNATE in China. We consolidate as revenue approximately 70-80% of ELUNATE in-market sales from manufacturing revenue, commercial service fees and royalties paid to us by Lilly. In the first half of 2024, we consolidated $46.0 million in revenue for ELUNATE , equal to 75% of in-market sales.
Following negotiations with the China NHSA54, ELUNATE continues to be included in the NRDL for a new two-year term starting in January 2024 at the same price as the 2023 NRDL price. We believe that ELUNATE is clearly differentiated from competitors such as regorafenib, which recently saw generic versions launched into the market.
In January 2024, ELUNATE was approved in Hong Kong. This was the first medicine to be approved under the new mechanism for registration of new drugs ("1+" mechanism).
Surufatinib (SULANDA in China)
SULANDA was launched in China in 2021 for the treatment of all advanced NETs55 for which we believe there is an approximate incidence of 40,000 new patients per year in China.
Total in-market sales in the first half of 2024 increased by 12% (17% at CER) to $25.4 million (H1-23: $22.6 million). According to IQVIA tracking study report in Q4 2023, SULANDA maintained its position in the market with 21% prescription share in NET treatment, ahead of competitors SUTENT and AFINITOR .
Following negotiations with the China NHSA, SULANDA continues to be included in the NRDL for a new two-year term starting in January 2024, at the same price as the 2023 NRDL price.
Surufatinib has been successfully recommended in 2023 "Chinese medical association consensus for standardized diagnosis and treatment of pancreatic cancer neuroendocrine neoplasms" and four other treatment guidelines for neuroendocrine tumors. As a result, doctors' acceptance and patients' access to SULANDA continue to increase.
Savolitinib (ORPATHYS in China)
ORPATHYS is the first-in-class selective MET inhibitor to be approved in China, launched and marketed by our partner, AstraZeneca for patients with METex14 NSCLC. More than a third of the world's lung cancer patients are in China. Among those with NSCLC globally, approximately 2-3% have tumors with METex14.
In-market sales for ORPATHYS increased 18% (22% at CER) in the first half of 2024 to $25.9 million (H1-23: $22.0m) resulting in our consolidation of $7.8 million (H1-23: $6.6m) in royalties and $5.3 million (H1-23: $8.5m) in manufacturing revenue, which benefited from an increase in channel inventory requirements in the first half of 2023 following the NRDL inclusion in March 2023.
Market understanding of the need for MET testing has improved significantly, with approximately half of new advanced/relapsed NSCLC patients in China being tested. In the National Health Commission's Treatment Guidelines for Primary Lung Cancer 2022 and the China Medical Association Oncology Committee Lung Cancer Group's China Medical Association Guideline for Clinical Diagnosis and Treatment of Lung Cancer, ORPATHYS was identified as the only targeted therapy recommended for MET exon 14 patients, while a similar guideline from CSCO56 also recommended ORPATHYS as the standard of care for such patients. As MET testing awareness and access increases, more patients are expected to be prescribed a selective MET inhibitor.
Tazemetostat (TAZVERIK in Hainan, Hong Kong and Macau, China; the US and Japan)
HUTCHMED has commercial rights to TAZVERIK in China. It is marketed in the US by Epizyme, Inc., an Ipsen57 company, and in Japan by Eisai Co., Ltd. In May 2022, TAZVERIK was approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Pilot Zone, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma consistent with the label as approved by the FDA. Tazemetostat was included in the 2022 CSCO guidelines for epithelioid sarcoma. Over 25 epithelioid sarcoma patients began treatment in the first half of 2024 (H1-23: 10). Tazemetostat is included in the 2023 CSCO guideline for follicular lymphoma. Sales in the Hainan Pilot Zone increased 40% (46% at CER) to $0.5 million (H1-23: $0.4m).
In July 2024, the NDA for tazemetostat for the treatment of adult patients with R/R follicular lymphoma was accepted for review and granted Priority Review by the NMPA.
In May 2024, TAZVERIK was approved in Hong Kong.
RESEARCH & DEVELOPMENT
With US and EU approvals of fruquintinib in November 2023 and June 2024, respectively, we now possess a track record of discovery, clinical development and marketing approval of an innovative medicine globally.
Our strategy is aimed at accelerating our path to establish a long-term sustainable business, by prioritizing late-stage and registrational studies in China and partnering outside of China. HUTCHMED intends to continue to run early phase development programs for selected drug candidates internationally where we believe we can differentiate from a global perspective.
Below is a summary update of the clinical trial progress of our investigational drug candidates. For more details about each trial, please refer to recent scientific publications.
Savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective oral inhibitor of MET. In global partnership with AstraZeneca, savolitinib is being studied in NSCLC, PRCC58 and gastric cancer clinical trials with about 2,600 patients to date, both as a monotherapy and in combinations. AstraZeneca has paid HUTCHMED $85 million of the total $140 million in upfront payments, development and approval milestones that are potentially payable under the relevant license and collaboration agreement.
MET-aberration is a major mechanism for acquired resistance to both first/second-generation EGFR TKIs59 as well as third-generation EGFR TKIs like TAGRISSO . Among patients who experience disease progression post-TAGRISSO treatment, approximately 15-50% present with MET aberration. The prevalence of MET amplification and overexpression may differ depending on the sample type, detection method and assay cut-off used. Savolitinib has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of three Phase III studies: SACHI and SANOVO were initiated in China in 2021, and the global, pivotal Phase III SAFFRON study started enrollment in 2022.
Savolitinib - NSCLC updates:
The table below shows a summary of the clinical studies for savolitinib in lung cancer patients.
| Treatment | Name, Line, Patient Focus | Sites | Phase | Status/Plan | NCT # | ||||||
| Savolitinib + TAGRISSO | SAVANNAH : 2L/3L EGFRm+ 60 ; TAGRISSO refractory; MET+ | Global | II Registration-intent | Fully enrolled Feb 2024; readout expected in late 2024 | NCT03778229 | ||||||
| Savolitinib + TAGRISSO | SAFFRON: 2L/3L EGFRm+; TAGRISSO refractory; MET+ | Global | III | Ongoing since 2022 | NCT05261399 | ||||||
| Savolitinib + TAGRISSO | SACHI : 2L EGFR TKI refractory NSCLC; MET+ | China | III | Ongoing since 2021 | NCT05015608 | ||||||
| Savolitinib + TAGRISSO | SANOVO : Na ve patients with EGFRm & MET+ | China | III | Ongoing since 2021 | NCT05009836 | ||||||
| Savolitinib monotherapy | MET exon 14 skipping alterations | China | II Registration | Approved & launched in 2021; Final OS analysis at ELCC 61 2022 | NCT02897479 | ||||||
| Savolitinib monotherapy | MET exon 14 skipping alterations | China | IIIb Confirmatory | Fully enrolled in H1 2023; 1L cohort data at WCLC 62 2023; Final 1L & 2L data at ELCC 2024; China NDA accepted in March 2024 | NCT04923945 |
The SAVANNAH global Phase II study in patients who have progressed following TAGRISSO due to MET amplification or overexpression has completed recruitment. In January 2023, the FDA designated as a Fast Track development program the investigation of savolitinib for use in combination with TAGRISSO for the treatment of patients with locally advanced or metastatic NSCLC whose tumors have MET overexpression and/or amplification, as detected by an FDA-approved test, and who have had disease progression during or following prior TAGRISSO . We will evaluate using the SAVANNAH study as the basis for US accelerated approval. In comparison to other treatments options, this treatment is chemotherapy-free, biomarker-specific and orally administered, aiming for a balanced efficacy, safety and quality-of-life profile for lung cancer patients.
The SAFFRON study, which will evaluate the efficacy and safety of savolitinib in combination with TAGRISSO compared to pemetrexed plus platinum doublet-chemotherapy, has now activated a majority of the approximately 250 sites in over 20 countries planned for the study.
Two registrational studies are ongoing in China in EGFR mutated NSCLC with MET aberrations: the SANOVO study in treatment na ve patients; and the SACHI study in patients whose disease progressed following treatment with any first-line EGFR TKI, which is expected to complete enrollment in 2024.
Update on MET altered, EGFR wild type NSCLC in China - The June 2021 monotherapy approval by the NMPA was based on positive results from a Phase II trial conducted in China in patients with NSCLC with METex14 (NCT02897479). Final results from a confirmatory Phase IIIb study in this patient population (NCT04923945) were disclosed at ELCC 2024, providing evidence for savolitinib as a targeted treatment option for treatment-na ve or previously treated patients with METex14 NSCLC.
n treatment-na ve patients, ORR was 62.1% (95% C : 51.0-72.3%)63, DCR was 92.0% (95% C : 84.1-96.7%) and median DoR64 was 12.5 months (95% C : 8.3-15.2), as assessed by independent review. Median PFS was 13.7 months (95% C : 8.5-16.6) and median OS was not reached with median follow-up of 20.8 months.
n previously treated patients, ORR was 39.2% (95% C : 28.4-50.9%), DCR was 92.4% (95% C : 84.2-97.2%) and median DoR was 11.1 months (95% C : 6.6- not reached), as assessed by independent review. Median PFS was 11.0 months (95% C : 8.3-16.6) and median OS was not mature with median follow-up of 12.5 months.
Responses occurred early (time to response 1.4-1.6 months) in both treatment-na ve and previously treated patients. The safety profile was tolerable and no new safety signals were observed. The most common drug-related treatment-emergent adverse events of Grade 3 or above (5% or more of patients) were abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), increased aspartate aminotransferase (12.0%), peripheral oedema (6.0%) and increased gamma-glutamyl transferase (6.0%).