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Ambrx Biopharma Halts Development of HER2 ADC ARX788, Cuts Workforce
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US-based, China-owned biotech Ambrx Biopharma Inc. (NYSE: AMAM) has announced plans to end the development of its HER2-targeted antibody drug conjugate (ADC) pipeline candidate ARX788. The decision follows a strategic assessment of factors including cash runway, pipeline near-term value creation opportunities, and other considerations. As a result, the company also…
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CATUG Biotechnology Partners with Duoning to Advance mRNA Industrialization
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China-based CATUG Biotechnology (Suzhou) Co., Ltd has entered into a partnership with compatriot firm Shanghai Duoning Biotechnology Co., Ltd, with the goal of strengthening the development of its mRNA industrialization platform. The collaboration aims to enhance the production capabilities and regulatory compliance of mRNA vaccines and drugs. No financial details…
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Betta Pharmaceuticals’ BPI-460372 Accepted for Clinical Trial Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that its clinical trial filing for the Category 1 drug candidate BPI-460372 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for the drug is advanced solid tumors, marking a significant step forward in the development of…
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Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s first homegrown innovative HIV therapy, has been approved. The approval allows the drug to be administered via intravenous bolus, significantly reducing the administration time. Alfusid: World’s First Long-Acting HIV DrugAlfusid is described as the world’s…
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Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) new indication filing for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the multi-kinase inhibitor famitinib, is set to receive Breakthrough Therapy Designation (BTD) status. The combination is intended as a…
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China Approves GSK’s Juluca for HIV-1 Infection
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The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE: GSK) Juluca (dolutegravir/rilpivirine), a dual therapy for adult patients infected with human immunodeficiency virus type 1 (HIV-1). This approval marks a significant milestone, as Juluca is the first dual therapy approved by the FDA for…
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Hengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for its CDK 4/6 inhibitor, dalpiciclib (SHR6390), as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast…
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HitGen Partners with C4X Discovery to Identify Novel Inflammatory Disease Treatments
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China-based HitGen Inc. (SHA: 688222) has announced a partnership with UK-headquartered C4X Discovery Holdings plc (AIM: C4XD) to identify novel, small-molecule hits against an inflammatory target for further development by C4XD. The collaboration leverages HitGen’s expertise in DNA-encoded library (DEL) screening technology to identify potential drug candidates. No financial details…
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Abbott Reports Q3 Sales Growth, Raises Full-Year EPS Guidance
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With the Q3 2022 reporting season underway, US-based medtech giant Abbott (NYSE: ABT) released its financials, showing sales of USD 10.4 billion, up 1.3% excluding foreign exchange impact. The performance was ahead of expectations, leading the company to raise its full-year guidance for earnings per share (EPS). Business Unit PerformanceBy…
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Shaanxi Releases Notice for Inter-Provincial Orthodontic Brackets VBP
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The Shaanxi Public Resources Trading Center has released the “Inter-provincial Alliance (regions, Corps) Orthodontic Brackets Volume-based Procurement (VBP) Notice.” This initiative aims to conduct volume-based procurement activities for orthodontic brackets in several provinces and autonomous regions, including Shaanxi, Shanxi, Inner Mongolia, Liaoning, Heilongjiang, Anhui, Henan, Guangxi, Hainan, Guizhou, Tibet, Gansu,…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention…
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Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for its BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), has been accepted for review by the European Medicine Agency (EMA). This marks a significant step forward in the global development and…
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Kactus Biosystems Raises RMB 200M in Series B Financing for Protein and Enzyme Development
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Kactus Biosystems, a Shanghai-based firm specializing in target proteins and raw enzymes, has raised RMB 200 million (USD 27.6 million) in a Series B financing round. The round was led by New Alliance Capital, with participation from Lingang Group’s healthcare industry fund, GF Capital, and a “famous multinational life science…
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Shandong Junxiu Biotechnology Secures RMB 45M in Series B Financing
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Shandong Junxiu Biotechnology Co., Ltd, a China-based maker of implantable regenerative medicine devices, has raised RMB 45 million (USD 6.2 million) in a Series B financing round. The round was led by Shenzhen Capital Group, with participation from Qianhai FOF, Huantong Venture Capital, and other investors. The proceeds will be…
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Brii Biosciences Reports Positive Phase I Results for HIV Treatments BRII-732 and BRII-778
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China-based Brii Biosciences Limited (HKG: 2137) has published the latest results of two Phase I clinical studies assessing its long-acting BRII-732 and BRII-778, both being developed to treat HIV infection, in healthy subjects in the US. The results showed that both BRII-732 and BRII-778 produced good safety and tolerability profiles…
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Bayer to Set Up Shenzhen Unit to Boost Women’s Healthcare in South China
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Bayer’s (ETR: BAYN) women’s healthcare unit for the South China region is reportedly planning to establish a Shenzhen regional unit, tasked with product promotion in Shenzhen and southern Guangzhou. The move is designed to reinforce Bayer’s prescription drug strategy in China and expand its women’s healthcare segment, according to the…
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GenScript’s Legend Biotech Reports USD 55M in Carvykti Sales
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has revealed that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of September 30, 2022. The drug is being commercialized in the…
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YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval
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China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house developed insulin aspart (specification 3ml: 300 units, refill) has been approved for marketing by the National Medical Products Administration (NMPA). This approval marks a significant milestone in the company’s efforts to expand its presence in…
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Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China. Previous Approvals and…
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NHSA Responds to Proposal on Dental Implants’ Inclusion in NRDL
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The National Healthcare Security Administration (NHSA) has responded to the No. 6184 suggestion from the 5th session of the 13th National People’s Congress regarding the inclusion of dental implants in the National Reimbursement Drug List (NRDL). The NHSA clarified that fixed and removable dentures are not covered by the NRDL,…
