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Innovent Biologics Doses First Volunteer in Orismilast Phase I Study
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China-based Innovent Biologics Inc., (HKG: 1801) and Denmark-based partner Union Therapeutics A/S revealed that a first healthy volunteer has been dosed in a Phase I study in China for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. The study (CTR 20222393) is a dose-escalation Phase I designed to assess the pharmacokinetic…
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Daiichi Sankyo Doses First Patient in Global Phase III TROPION-Lung08 Study
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without…
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Tsingke Biotech Secures RMB 400M Series B Financing for Expansion
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Beijing Tsingke Biotech Co., Ltd. a gene synthesis company based in Beijing, reportedly raised RMB 400 million (USD 57.5 million) in a Series B financing round. The round was co-led by Henan Investment Group Huirong Fund Management Co., Ltd and Fortune Capital. Other investors included Capitallink, Qingsong Fund, Zhongyuan Asset…
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China Medical System Licenses Opzelura from Incyte for Greater China and Southeast Asia
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China Medical System Holdings (CMS; HKG: 0867) announced the establishment of a licensing agreement with US-based Incyte Pharmaceuticals Inc., (NASDAQ: INCY) focused on Incyte’s Opzelura (ruxolitinib) cream. As per the agreement, which will initially last 10 years, the Chinese firm will take exclusive research and development (R&D), regulatory filing, and…
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SAFE Raises RMB 500M in Series D Financing to Expand CRO Services
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Serve Accurate Faithful Evaluation (SAFE), a contract research organization (CRO) co-founded by the Chinese Academy of Sciences (CAS) in 2016, reportedly raised around RMB 500 million (USD 71.9 million) in a Series D financing round. The firm previously raised RMB 300 million (USD 43.1 million) via a Series C funding…
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Peijia Medical Enrolls First Patient in GeminiOne TEER System Study
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China’s Peijia Medical Ltd (HKG: 9996) announced first patient enrollment in a multi-center clinical study for its transcatheter edge-to-edge repair (TEER) system GeminiOne in China. The first operation went smoothly, with the whole device being manipulated for a mere 30 minutes. The prospective regulatory, multi-center, target value study is designed…
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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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Yifan Pharma Transfers F-627 Distribution Rights in Germany to Apogepha
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the transfer of exclusive distribution rights in Germany to its efbemalenograstim alfa (F-627), to Apogepha Arzneimittel GmbH. The German firm will pay Yifan Pharma a USD 400,000 upfront payment, up to USD 1 million development milestone payment, and up to USD 37.5…
