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China’s 7th VBP Round Yields 65.5% Drug Price Cuts, Foreign Firms Secure Bids
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China’s 7th national volume-based procurement (VBP) round concluded with winning bids averaging a 65.5% price reduction compared to ceiling prices, as domestic firms dominated the tender. The results, announced by the national alliance procurement office, are open for public feedback until July 15, with full province-by-province allocations pending. Key Results…
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CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
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The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou Ascentage Pharma’s olverembatinib and Roche’s crovalimab. The designations aim to accelerate regulatory timelines for these therapies targeting unmet medical needs. Ascentage’s Olerembatinib Roche’s Crovalimab
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Athenex Sells China Subsidiaries to TiHe Capital for USD 19 Million
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US-based Athenex Inc. (Nasdaq: ATNX) announced an agreement to sell all equity interests in its China-based subsidiaries, primarily involved in active pharmaceutical ingredient (API) manufacturing, to China’s TiHe Capital (Beijing) Co., Ltd for RMB 124.4 million ($19 million). The deal, subject to customary closing conditions, will see Athenex receive ~70%…
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Tasly Pharmaceuticals and Mauna Kea Form JV to Commercialize Cellvizio in China
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China-based Tasly Pharmaceuticals (SHA: 600535) announced a joint venture (JV) with France’s Mauna Kea Technologies (Paris: MKEA) to commercialize the Cellvizio platform in China and develop it globally for neurology and neurosurgery. The JV will hold exclusive rights to Cellvizio for certain indications in China and global rights for neurological…
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MicroPort MedBot’s Honghu Robot Wins FDA 510(k) Certification for Joint Replacement
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that its in-house developed orthopedic surgery robot Honghu has received 510(k) certification from the US FDA, marking it as the first and only home-grown surgical robot approved in the US. Product HighlightsDesigned for joint replacement surgery, the Honghu robot offers accurate,…
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Venus Medtech’s Transcatheter Prosthetic Pulmonary Valve Approved by NMPA
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The National Medical Products Administration (NMPA) has approved Venus Medtech (Hangzhou) Inc’s (HKG: 2500) transcatheter prosthetic pulmonary valve system for marketing, marking a milestone for the company’s innovative cardiac device. Product OverviewThe system comprises a self-expanding nickel-titanium alloy stent, porcine pericardium leaflets, and a delivery mechanism. The valve’s design enhances…
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Hengrui Medicine’s SHR-1701 + Ameile Combo Greenlit for EGFR-Mutated NSCLC Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved an open, multi-center Phase Ib/II clinical study of its fusion protein SHR-1701 combined with Ameile (aumolertinib) for EGFR-mutated recurrent or advanced non-small cell lung cancer (NSCLC). Drug ProfileSHR-1701 targets PD-L1 and TGF-βRII,…
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Eucure Biopharma Doses First Patient in YH003 + Keytruda Trial for Mucosal Melanoma
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Eucure Biopharma, a subsidiary of Sino-US contract research organization Biocytogen, announced that the first patient has been dosed in a Phase II clinical study in China for a combination regimen of its CD40 monoclonal antibody (mAb) YH003 with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) and albumin paclitaxel. The trial targets first-line…
