HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda in China) for Advanced Pancreatic Neuroendocrine Tumors - Second New Drug Application ("NDA") approved for Sulanda in China - - The pivotal Phase III SANET-p trial

HUTCHMED Announces NMPA Approval of Surufatinib

(Sulanda in China) for Advanced Pancreatic Neuroendocrine Tumors

- Second New Drug Application

("NDA") approved for Sulanda in China -

- The pivotal Phase III SANET-p

trial demonstrated surufatinib reduced risk of progression or death by 51% in patients with advanced pancreatic NET -

Hong Kong, Shanghai, & Florham Park, NJ:

Friday, June 18, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today announces that surufatinib has been

granted approval for drug registration by the National Medical Products Administration of China ("NMPA") for the treatment

of advanced pancreatic neuroendocrine tumors ("pNETs"). This follows the approval of surufatinib in China in December 2020

for the treatment of advanced extra-pancreatic (non-pancreatic) neuroendocrine tumors ("epNETs").

The Company was made aware through the website

of the NMPA that surufatinib's approval for drug registration by the NMPA for the treatment of pNETs was completed and is now pending

Christian Hogg, Chief Executive Officer of HUTCHMED,

commented, "Since its launch in January this year, patients with epNETs have benefited from treatment with surufatinib through its

unique mode of action by both inhibiting angiogenesis and promoting the body's immune response against tumor cells. With today's

approval, we are now able to provide this unique therapy to NET patients with pancreatic tumor origin as well."

Surufatinib is marketed in China under the brand

HUTCHMED's oncology commercial team today

covers more than 2,500 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization

in China with deep knowhow in the field of NETs.

This NMPA approval was supported by the SANET-p

study, a Phase III pivotal study (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pancreatic NETs conducted in China.

The study met the pre-defined primary endpoint of progression-free survival ("PFS") at a preplanned interim analysis and was

stopped early. The positive results of this trial were highlighted in an oral presentation at the 2020 ESMO Congress and published in

The Lancet Oncology1 in September 2020. Median PFS was 10.9 months for patients treated with surufatinib, as compared to 3.7

months for patients in the placebo group (hazard ratio ["HR"] 0.491; 95% confidence interval ["CI"] 0.391-0.755;

p=0.0011). Benefit was observed across most major subgroups of pNET patients. The safety profile of surufatinib was manageable

and consistent with observations in prior studies. Treatment was well tolerated for most patients, with discontinuation rates as a result

of treatment emergent adverse events of 10.6% in the surufatinib group as compared to 6.8% in the placebo group.

In China, there were an estimated 71,300 newly

diagnosed NET patients in 2020. Considering the current incidence to prevalence ratio, there may be as many as 300,000 patients living

NETs form in cells that interact with the nervous

system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can

be benign or malignant. NETs are typically classified as pNET or epNET. Approved targeted therapies include Sutent (for

pNET only) and Afinitor for pNET and well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,700

newly diagnosed cases of NETs in the U.S. in 2020. Importantly, NETs are associated with a relatively long duration of survival compared

About Surufatinib (Sulanda

Surufatinib is a novel, oral angio-immuno kinase

inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and

fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates

tumor-associated macrophages, promoting the body's immune response against tumor cells. Its unique dual mechanism of action may

be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib

About Other Surufatinib Development

NETs in the U.S. and Europe: In the U.S.,

surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET

in November 2019. A U.S. FDA NDA was submitted on April 30, 2021, and a MAA submission to the European Medicines Agency (EMA) is planned.

The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S.

epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937).

epNETs in China: On December 30, 2020,

surufatinib was granted drug registration approval by the NMPA for the treatment of epNET. Surufatinib is marketed in China under the

brand name Sulanda . The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier:

NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned

interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published

in The Lancet Oncology in September 2020.3 Median PFS was significantly longer for patients treated with surufatinib

at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib

had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of

surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

Biliary tract cancer in China: In March

2019, HUTCHMED initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer

whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).

Immunotherapy combinations: HUTCHMED entered

into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal

antibodies, including with tislelizumab (BGB-A317), Tuoyi (toripalimab) and Tyvyt (sintilimab), which

are approved as monotherapies in China.

HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison

China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development

and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization

of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its

Forward-Looking Statements

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 reflect HUTCHMED's current expectations regarding future events, including its expectations regarding

the commercial launch of surufatinib in China, the ability of its in-house oncology sales team to distribute surufatinib quickly and broadly,

the potential market for surufatinib in NET patients in China, and the further clinical development for surufatinib in these and other

indications in China, the United States and other jurisdictions. Forward-looking statements involve risks and uncertainties. Such risks

and uncertainties include, among other things, assumptions regarding HUTCHMED's ability to commercialize surufatinib, the benefits

obtained from surufatinib during clinical trials being the same for all patients who are prescribed surufatinib, no unidentified side

effects occurring which could result in the NMPA pulling surufatinib from the market, HUTCHMED's ability to fund, implement and

complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the

COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine,

tislelizumab, Tuoyi , and Tyvyt as combination therapeutics with surufatinib, such risks and uncertainties

include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective

investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further

discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED

undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future

events or circumstances or otherwise.

This announcement contains inside information

for the purposes of Article 7 of Regulation (EU) No 596/2014.

Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled,

phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.

2 According to Frost & Sullivan.

The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment

3 Xu J, Shen L, Zhou Z, et al. Surufatinib

in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published

online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.