The increased availability of capital, greater access to talent, strong local governmental support and more focused attention on IP issues have increased the complexity of deals taking place between biotech and big pharma companies in China, according to Michelle Chan, chief business officer of Insilico Medicine Inc.
Likang Life Sciences Holdings Ltd. received approval from China’s NMPA to start a clinical trial of its candidate, LK-101 injection, for advanced solid tumors. The company claims this is the first personalized neoantigen vaccine and mRNA editing product to enter the clinic in China.
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Health Guard Biotechnology Inc. raised ¥294 million (US$43 million) in an IPO on the SME-focused Beijing Stock Exchange, with the funds going to push the development of its HPV vaccines.
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK-021), is advancing from phase I trials to pivotal phase III trials in patients with tenosynovial giant cell tumors (TGCT) in the U.S. and China following clearance from both regulators.
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon, which is based in Guangdong, China, obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Seoul, Korea-based Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments.
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
Oricell Therapeutics Co. Ltd. raised $45 million in a series B1 round to expand in the U.S. market. RTW Investments LP and the Qatar Investment Authority led the financing, which followed the completion of a $125 million series B round in July 2022. Shanghai-based Oricell plans to use the new funds to support the clinical development of its lead candidates, including Oricar-017, in the U.S.
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