LONDON, Nov. 25, 2019 (GLOBE NEWSWIRE) — Hutchison China MediTech Restricted (“Chi-Med”) (AIM/Nasdaq: HCM) right this moment pronounces that the U.S. Meals and Drug Administration (“FDA”) has granted Orphan Drug designation to surufatinib for the therapy of pancreatic neuroendocrine tumors (“NET”).
“NET is an space of serious unmet medical want. The present therapy choices are very restricted,” stated Christian Hogg, CEO of Chi-Med. “The FDA granting Orphan designation is a constructive step and continues to strengthen the significance of our analysis and improvement in bringing surufatinib to extra sufferers in want.”
If authorized by the FDA as an orphan therapy, surufatinib will probably be entitled to seven years of market exclusivity for the authorized indication. Orphan Drug designation additionally affords sure improvement value advantages within the U.S.
Surufatinib is underneath investigation in a number of stable tumors in China and the U.S., each as a monotherapy and together with immunotherapies.
Surufatinib is the second novel oncology drug found by Chi-Med to efficiently full a Part III trial in China. A New Drug Software (“NDA”) for surufatinib for the therapy of sufferers with superior non-pancreatic NET was accepted for assessment by the China Nationwide Medical Merchandise Administration (NMPA) on November 11, 2019.
About FDA Orphan Drug Designation
The FDA Orphan Drug Designation Program gives orphan standing to medication and biologics that are outlined as these supposed for the protected and efficient therapy, analysis or prevention of rarer illnesses/issues that have an effect on fewer than 200,000 individuals within the U.S., or that have an effect on greater than 200,000 individuals however usually are not anticipated to recuperate the prices of creating and advertising and marketing a therapy drug.
Surufatinib (beforehand often called HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase exercise related to vascular endothelial development issue receptor (“VEGFR”) and fibroblast development issue receptor (FGFR), which each inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, selling the physique’s immune response towards tumor cells. Its distinctive twin mechanism of motion could also be very appropriate for potential mixtures with different immunotherapies. Surufatinib is in a number of late-stage and proof-of-concept medical trials in China and proof-of-concept medical trials within the U.S.
In accordance with Frost & Sullivan, the marketplace for anti-angiogenesis VEGF/VEGFR inhibitors in China has grown from US$500 million in 2015 to over US$1.5 billion in 2019 and is predicted to achieve US$5 billion by 2026.
Chi-Med presently retains all rights to surufatinib worldwide.
Non-Pancreatic neuroendocrine tumors in China: In 2015, we initiated the SANET-ep examine, a Part III examine of surufatinib in superior neuroendocrine tumors – extra-pancreatic sufferers in China for whom there isn’t a efficient remedy. In June 2019, a 198 affected person interim evaluation was carried out, main the unbiased knowledge monitoring committee to find out that the examine met the pre-defined major endpoint of progression-free survival (“PFS”) and ought to be stopped early.
Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p examine, which is a pivotal Part III examine in sufferers with low- or intermediate-grade, superior pancreatic neuroendocrine tumors in China. The first endpoint is PFS. We count on an interim evaluation within the first half of 2020 and enrollment to finish in 2020 ( identifier: NCT02589821).
Neuroendocrine tumors within the U.S. and Europe: We’re planning a U.S. registration examine in neuroendocrine tumors sufferers based mostly on the encouraging knowledge from the Part II and Part III research of surufatinib in neuroendocrine tumors in China ( identifier: NCT02267967), and the continuing Part Ib examine within the U.S. ( identifier: NCT02549937).
Biliary tract most cancers in China: In March 2019, we initiated a Part IIb/III examine evaluating surufatinib with capecitabine in sufferers with superior biliary tract most cancers whose illness progressed on first-line chemotherapy. The first endpoint is general survival (OS) ( identifier NCT03873532).
Immunotherapy mixtures: In November 2018 and September 2019, we entered into collaboration agreements to judge the security, tolerability and efficacy of surufatinib together with anti-programmed cell dying protein 1 (PD-1) monoclonal antibodies. This included international collaborations to judge the mix of surufatinib with Tuoyi®, authorized in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt®, authorized in China by Innovent Biologics, Inc.
About Neuroendocrine Tumors (NET)
Neuroendocrine tumors kind in cells that work together with the nervous system or in glands that produce hormones. They’ll originate in numerous elements of the physique, most frequently within the intestine or the lungs and might be benign or malignant. Neuroendocrine tumors are sometimes categorized as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. Authorised focused therapies embrace Sutent® and Afinitor® for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.
In accordance with Frost and Sullivan, there have been 19,000 newly identified instances of neuroendocrine tumors within the U.S. in 2018. Importantly, neuroendocrine tumors are related to a comparatively lengthy period of survival in comparison with different tumors. In consequence, there have been roughly 141,000 estimated sufferers residing with neuroendocrine tumors within the U.S. in 2018 of which over 90%, or roughly 132,000, have been non-pancreatic neuroendocrine tumor sufferers.
In China, there have been roughly 67,600 newly identified neuroendocrine tumor sufferers in 2018 and, contemplating the present incidence to prevalence ratio in China, probably as many as 300,000 sufferers residing with the illness within the country1. It’s estimated that roughly 80% of the sufferers residing with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor sufferers.
Chi-Med (AIM/Nasdaq: HCM) is an revolutionary biopharmaceutical firm which researches, develops, manufactures and markets pharmaceutical merchandise. Its Innovation Platform, Hutchison MediPharma, has about 470 scientists and workers specializing in discovering, creating and commercializing focused therapeutics and immunotherapies in oncology and autoimmune illnesses. It has a portfolio of eight most cancers drug candidates presently in medical research all over the world. Chi-Med’s Industrial Platform manufactures, markets, and distributes prescribed drugs and shopper well being merchandise, protecting an intensive community of hospitals throughout China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Inventory Change and the Nasdaq International Choose Market. For extra data, please go to:
This press launch accommodates forward-looking statements inside the that means of the “protected harbor” provisions of the U.S. Non-public Securities Litigation Reform Act of 1995. These forward-looking statements mirror Chi-Med’s present expectations relating to future occasions, together with its expectations relating to the NDA approval and launch of surufatinib for the therapy of sufferers with non-pancreatic NET in China, the additional medical improvement of surufatinib on this and different indications, its expectations as as to if medical research of surufatinib would meet their major or secondary endpoints, and its expectations as to the timing of the completion and the discharge of outcomes from such research. Ahead-looking statements contain dangers and uncertainties. Such dangers and uncertainties embrace, amongst different issues, assumptions relating to the sufficiency of its knowledge to help NDA approval of surufatinib for the therapy of sufferers with non-pancreatic NET in China, its potential to achieve expeditious approvals for surufatinib in different jurisdictions such because the U.S. and EU, the security profile of surufatinib, the potential for surufatinib to turn into a brand new commonplace of look after non-pancreatic NET sufferers, its capacity to implement and full its additional medical improvement plans for surufatinib, its potential business launch of surufatinib in China and different jurisdictions and the timing of those occasions. Current and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date hereof. For additional dialogue of those and different dangers, see Chi-Med’s filings with the U.S. Securities and Change Fee and on AIM. Chi-Med undertakes no obligation to replace or revise the knowledge contained on this press launch, whether or not on account of new data, future occasions or circumstances or in any other case.
1 In accordance with Frost & Sullivan, in 2018, there have been 19,000 newly identified instances of NETs in the usand an estimated 141,000 sufferers residing with NETs. The present incidence to prevalence ratio in China is estimated at 4.4, decrease than the 7.Four ratio within the U.S. as a result of decrease entry to therapy choices.
Posted: November 2019