Non Functioning Pancreatic Endocrine Tumor

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM, HKEX:​13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement. Mr Hong Chen, Senior Vice President and Chief Commercial Officer (China) of HUTCHMED, said: “The NRDL has made it possible for our innovative medicines to quickly reach more patients in need across China. In the past few years, we have seen an array of new measures adopted by the NHSA, including the NRDL negotiation, the bidding process for non-exclusive medicines and simplified renewal rules for already listed medicines. Those new measures provided a solid foundation for the sustainable development of the innovative pharmaceutical industry and continuous improvement of patients’ access to innovative medicines, allowing patients to truly benefit from healthcare innovations.” ELUNATE® was first included in the NRDL on January 1, 2020, for the treatment of metastatic colorectal cancer (“CRC”). CRC was the third most diagnosed form of cancer by incidence in China in 2020, with an estimated 555,000 new cases each year.1 SULANDA® was first included in the NRDL on January 1, 2022, for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (“NETs”). In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.2 About the NRDL The government in China has placed great importance on improving the affordability of drug treatments for the public. As of 2022, 1.35 billion people in China had basic medical insurance coverage, representing around 95% of the entire population. The NRDL is updated every year, and inclusion on the list is subject to renewal every two years. The NHSA annually convenes a broad network of experts in medicine, pharmacology, pharmacoeconomics and actuarial valuation to identify innovative medicines to consider for NRDL inclusion. Reimbursement of Category B medicines, including novel oncology medicines, requires varying degrees of copayment from patients, depending on their province or type of NHSA insurance scheme enrollment. About Fruquintinib Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”)-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies. Fruquintinib is marketed in China by HUTCHMED under the brand name ELUNATE® following its approval in September 2018, in partnership with Eli Lilly and Company. Fruquintinib is marketed in the United States by its partner Takeda under the brand name FRUZAQLA™, following its approval in November 2023. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with 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. It is marketed in China by HUTCHMED under the brand name SULANDA®. About HUTCHMED HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) 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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release 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 for the commercialization of fruquintinib and surufatinib in China, the potential benefits and further clinical development of fruquintinib and surufatinib, its expectations as to whether further studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the commercial acceptance of fruquintinib and surufatinib, the impact of the inclusion of fruquintinib and surufatinib on the NRDL on sales of the drug and its pricing, clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of fruquintinib and surufatinib to obtain regulatory approval for a targeted indication in different jurisdictions and the sufficiency of funding. In addition, as certain studies rely on the use of osimertinib or durvalumab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval and the impact of COVID-19 on general economic, regulatory and political conditions. 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, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release 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. CONTACTS Investor Enquiries+852 2121 8200 / +1 973 306 4490 / 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.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500 1 The Global Cancer Observatory. Accessed November 23, 2023.2 According to Frost & Sullivan. Report on file.

Lutathera was the first product from Novartis’ now growing radiotherapy portfolio to reach the market. More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs. The cancer is called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the study, combining Lutathera with Novartis’ long-acting Sandostatin significantly extended the time before disease progression or death compared with high-dose Sandostatin alone in newly diagnosed patients with somatostatin receptor-positive stage 2 and 3 GEP-NETs, the company said Monday. Lutathera has been approved in the U.S. alongside Sandostatin for previously treated GEP-NETs since 2018. The positive phase 3 NETTER-2 trial readout now makes Lutathera the first radioligand therapy to show a clinically meaningful progression-free survival benefit in any first-line cancer setting, Novartis pointed out. Novartis will discuss the results with regulatory authorities and share them at an upcoming medical meeting. NETs are rare and can be found in the neuroendocrine system across the digestive tract, the lungs and pancreas. While grade 1 tumors grow slowly, higher grade NETs are more aggressive.   Treatment options are few. Besides Lutathera and Sandostatin, Novartis’ Afinitor and Pfizer’s Sutent are also used to treat NETs. In China, Hutchmed in 2020 introduced surufatinib, marketed as Sulanda, initially to treat non-pancreatic NETs. But the drug suffered an FDA rejection last year, and Hutchmed has also withdrawn its application with the European Medicines Agency. Lutathera was the first product from Novartis’ radiotherapy portfolio to reach the market. The drug generated $299 million in the first half of the year, representing 42% growth over the same period last year. Lutathera has recently been upstaged by Novartis’ second radiopharmaceutical treatment, the prostate cancer therapy Pluvicto. Approved by the FDA last March for previously treated PSMA-positive metastatic castration-resistant prostate cancer, Pluvicto pulled in $451 million in sales in the first six months of 2023. Trying to also move Pluvicto into earlier lines of treatment, Novartis recently touted the phase 3 PSMAfore win. The positive readout could enable the use of the drug before patients get taxane-based chemotherapy and triple or quadruple its addressable patient base. The clinical success of Pluvicto stress-tested Novartis’ radiotherapy production capacity, leading to a few months of supply shortfalls earlier this year. Novartis also temporarily stopped producing Pluvicto and Lutathera last May at two facilities in Italy and New Jersey after spotting some potential manufacturing issues. Novartis has expanded its existing radioligand therapy manufacturing sites and is awaiting FDA clearance for a new facility in Indianapolis, which is expected to be operational this year. Besides NETs, Novartis is also in phase 2 tests of Lutathera against brain cancer and small cell lung cancer.

Adrenal cortex is the outer layer of the gland involved in production of lifesaving hormones such as mineralocorticoids and glucocorticoids (aldosterone and cortisol) required for metabolism and stress management. Adrenal glands are located on the top of the kidneys. Adrenal cortical carcinoma is the cancer of adrenal cortex. There are two types of tumor associated with adrenal cortex, such as functioning tumor and non-functioning tumor. Functioning tumor is responsible for increase in the production of adrenal hormones, whereas, non-functioning tumor does not affect hormonal production. Adrenal cortical carcinoma is generally a secondary type of cancer. It occurs when another form of cancer spreads into the adrenal glands. Request Brochure of Report - Increasing incidence of adrenal cortical carcinoma due to spread of other form of cancer, advancement in imaging technologies to identify adrenal cortical tumors specifically, growing healthcare expenditure, and rising number of cancer treatment centers across the world are some of the dominating factors expected to fuel the growth of the global adrenal cortical carcinoma diagnosis and treatment market during the forecast period. For instance, according to the Journal of Clinical Endocrinology & Metabolism, adrenal cortical carcinoma is a rare and highly aggressive malignancy. The incidence rate for adrenal cortical carcinoma is 0.7–2.0 cases per million people. The disease is more common in women. It is generally diagnosed in the age group of 40 and 50 years. However, high incidence of adrenal cortical carcinoma is recorded among children in Brazil due to the high prevalence of a specific TP53 germline mutation in them. Request for Custom Research - The global adrenal cortical carcinoma diagnosis and treatment market can be segmented based on type of test, type of therapy, end-user, and region. In terms of type of test used for the diagnosis of adrenal cortical carcinoma, the market can be divided into magnetic resonance imaging (MRI), computed tomography (CT) scan, positron emission tomography (PET) scan, and biopsy. In terms of type of therapy, the adrenal cortical carcinoma diagnosis and treatment market can be categorized into surgery, chemotherapy, other drug therapy, radiation therapy, and biologic therapy. The surgery therapy segment can be further categorized into laparoscopic surgeries and open surgeries. The chemotherapy segment can be classified based on the type of drug used for the treatment into mitotane and the combination therapy of cisplatin, doxorubicin (adriamycin), and etoposide (VP-16) plus mitotane. The other drug therapy segment involves treatment of hormonal effects caused by the tumor. Drugs included in this type of therapy are spironolactone, mifepristone, tamoxifen, toremifene, etc. The radiation therapy segment can be bifurcated into external beam radiation therapy and brachytherapy. In terms of end-user, the adrenal cortical carcinoma diagnosis and treatment market can be segmented into hospitals, specialty cancer clinics, diagnostic centers, and others. Pre Book Adrenal Cortical Carcinoma Diagnosis and Treatment Market Report at - Based on geography, the global adrenal cortical carcinoma diagnosis and treatment market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is expected to dominate the adrenal cortical carcinoma diagnosis and treatment market owing to high per capita disposable income and increasing incidence of the adrenal cortical carcinoma in the region. For instance, according to the American Cancer Society, adrenal tumors (most of which are benign adenomas) are found in 1 in every 10 people who undergo tests such as CT scan or MRI of the adrenal gland. Europe is expected to be the second leading market for semen analysis due to high awareness about early diagnosis and treatment of the disease, favorable reimbursement facilities, and increasing healthcare expenditure in the region. Asia Pacific can be considered as an emerging market for the diagnosis and treatment of adrenal cortical carcinoma. Key players operating in the global adrenal cortical carcinoma diagnosis and treatment market include HRA Pharma, ER Squibb & Sons LLC, Bristol-Myers Squibb Company, GE healthcare, WG Critical Care, LLC, David Bull Laboratories (Pty) Ltd., Mylan Pharmaceuticals, Fresenius Kabi, Pfizer, SINOVISION Technologies(Beijing) Co., Ltd., Hitachi Medical Systems, NeuroLogica Corp., and Digirad Corporation. 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