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Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
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Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for treating inoperable giant cell tumor of tendon sheath. The drug, a CSF-1R inhibitor, is being developed for both tumor and non-tumor indications.…
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NMPA Reclassifies Glucosamine Sulfate to OTC, Mandates Label Revisions
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China’s National Medical Products Administration (NMPA) announced that potassium glucosamine sulfate has been reclassified from a prescription drug to over-the-counter (OTC) status. The move requires updates to product listings and OTC package insert templates. Regulatory UpdateMarketing Authorization Holders (MAHs) must submit revised package inserts to provincial medical products bureaus by…
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China’s JPO Launches VBP Round for Orthopedic Spine Consumables
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China’s Joint Procurement Office (JPO) announced plans on July 11 to conduct a volume-based procurement (VBP) round for orthopedic spine medical consumables, marking the third such initiative following previous rounds for coronary stents and artificial joints. The three-year cycle aims to standardize procurement and reduce costs. Bidding StructureThe JPO will…
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HutchMed’s Orpathys-Tagrisso Combo Shows Promise in NSCLC at WCLC
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH Phase II trial results at the World Conference of Lung Cancer (WCLC). The study evaluates the combination of HutchMed’s Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib) in EGFR-mutated, MET-driven non-small cell lung cancer (NSCLC) patients with…
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Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA) has approved its injectable bispecific antibody (BsAb) JS203 for a clinical study in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The drug targets CD20 and CD3, leveraging these antigens to enhance tumor-inhibiting effects. Drug Profile…
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Eli Lilly’s Trulicity + Insulin Combo Meets Goals in China’s AWARD-CHN3 Study
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Eli Lilly (NYSE: LLY) announced that its Phase III AWARD-CHN3 study of Trulicity (dulaglutide) combined with titrated insulin glargine in Chinese patients with type 2 diabetes met the primary endpoint and all key secondary endpoints. The 28-week trial showed significant reductions in glycated hemoglobin (HbA1c), body weight, and fasting serum…
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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…
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Overland ADCT BioPharma Launches Global Phase III Trial for Zynlonta in DLBCL
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Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the initiation and first patient dosing of the global Phase III LOTIS-5 trial for Zynlonta (loncastuximab tesirine), an anti-CD19 antibody-drug conjugate (ADC). The study will evaluate Zynlonta in combination with rituximab as…
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Bio-Thera Solutions Doses First Patient in BAT8006 Phase I Study for Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that the first patient has been dosed in a Phase I clinical study of BAT8006, an in-house developed antibody drug conjugate (ADC) targeting folate receptor alpha (FRα), for advanced solid tumors. The multi-center, open-label trial will assess the drug’s safety, tolerability, and preliminary efficacy.…
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Neurophth and Abogen Partner on mRNA Therapy for Retinal Diseases
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China-based Neurophth Biotechnology Ltd, a gene therapy specialist, has partnered with compatriot mRNA drug developer Abogen Biosciences Co., Ltd to develop lipid nanoparticles (LNPs) for mRNA delivery targeting retinal diseases. The collaboration combines Neurophth’s expertise in ophthalmology gene therapy with Abogen’s mRNA and LNP technology. Partnership DetailsThe partnership aims to…
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Hong Kong Researchers Explore TES for Depression and Alzheimer’s Treatment
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Researchers at The University of Hong Kong’s Li Ka Shing Faculty of Medicine (HKUMed) and City University of Hong Kong (CityU) have conducted two preclinical studies demonstrating the therapeutic potential of transcorneal electrical stimulation (TES) in treating depression and Alzheimer’s disease. The findings suggest that TES, a minimally invasive approach,…
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CASI Pharmaceuticals Invests in Precision Immune Therapeutics for CID-103 Development
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US-based CASI Pharmaceuticals Inc. (NASDAQ: CASI) announced the completion of a financing round for China’s Precision Immune Therapeutics (PAT), securing RMB 140 million ($21 million) for the firm. CASI invested RMB 20 million ($3 million) to take a 15% stake, alongside two other venture capital firms. Financing DetailsThe funding round…
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Sinopharm in Talks to Acquire BBI Life Sciences in USD 1B+ Deal
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China National Pharmaceutical Group Co., Ltd (Sinopharm) is reportedly considering a bid to acquire Shanghai-based BBI Life Sciences Corp., with a potential deal valued at over USD 1 billion, according to Bloomberg. The news cites insider sources stating Sinopharm has held preliminary talks with BBI’s founding Wang family, while other…
