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Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan Food and Drug Administration (TFDA) for its drug Xpovio (selinexor) in three indications. The approvals cover the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large…
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AIM Vaccine Receives CDE Approval for Serum-Free Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its investigational lyophilized human rabies vaccine (serum-free Vero cells). This approval marks a significant step forward in the company’s efforts to develop and commercialize innovative rabies vaccines. Vero Cells…
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Rici Healthcare to Acquire Unicorn II Holdings for RMB 180M
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China-based Rici Healthcare Holdings Limited (HKG: 1526), also known as Rich Healthcare, is set to acquire 1,672,140 shares of Unicorn II Holdings Limited for RMB 180 million (USD 24.7 million). The acquisition aims to strengthen Rici Healthcare’s position in the rapidly growing private medical services sector in China. Market Growth…
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Roche Reports Q3 Sales Growth, Hit by COVID-19 Product Decline
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2022 financial report last week, showing group sales up 2% year-on-year (YOY) at constant exchange rates (CER) during the 9-month period to CHF 47.0 billion (USD 46.8 billion). The growth rates for Q1, Q2, and Q3 were +11%, +0%, and -6%…
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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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Sinopharm’s Wuhan Institute Isolates Monkeypox Strains, Begins Vaccine Research
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China’s Wuhan Institute of Biological Products, a research affiliate of Sinopharm’s China National Biotech Group (CNBG), has announced that it has successfully isolated monkeypox strains from clinical samples. This development marks a significant step in the global effort to combat the infectious disease. Research has now begun on developing vaccines…
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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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Fujian Procurement Center Announces VBP for Cardiac and Laparoscopic Medical Consumables
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The Fujian drug and device joint procurement center has released two separate notifications regarding the inter-provincial alliance volume-based procurement (VBP) of medical consumables. The initiatives target cardiac intervention electrophysiology and endoscopic cutting stapler/suture products. The documents outline the specific procurement modes, selection rules, and other details. The time for enterprise…
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NMPA Releases 61st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 61st batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 57 new specifications and 18 specifications with modifications, highlighting the ongoing efforts to ensure the quality and consistency of generic drugs in China. Inclusion of Biogen’s…
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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…
