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Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
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Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid…
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VectorBuilder Raises $56.6M in Series C to Expand Life Science R&D
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Guangzhou-based VectorBuilder, a genetic engineering specialist incubated by the state-owned Guangzhou Industrial Investment and Capital Operation Holding Group, has reportedly raised RMB 410 million ($56.6 million) in a Series C financing round. The funding round saw participation from investors including Guangzhou Industrial Investment and Capital Operation, Legend Capital, Yuexiu Industry…
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WuXi Biologics Removed from US Unverified List Amid Ongoing Restrictions
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The US Commerce Department’s Bureau of Industry and Security (BIS) has updated its Unverified List (UVL), removing WuXi Biologics (HKG: 2269), a contract research organization (CRO) based in Wuxi, China. However, the US authorities have added 31 additional Chinese companies and universities to the list, including Shanghai Tech University, University…
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India Launches Anti-Dumping Investigation Against Chinese Imports of Metronidazole
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The Union Ministry of Commerce and Industry in India has initiated an anti-dumping investigation into imports of the antibiotic metronidazole, following a complaint filed by Aarti Drugs Ltd., one of the largest manufacturers of the drug in the country. Complaint DetailsAarti Drugs alleges that Chinese companies aredumping metronidazole at prices…
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China’s NMPA Proposes Reforms to Enhance Radiopharmaceutical Review and Approval
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China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming and Improving the Administration of Review and Approval of Radiopharmaceuticals,” seeking public feedback. The document outlines a series of reforms aimed at enhancing the regulatory framework for radiopharmaceuticals in the country. Expanding Expertise in Radiopharmaceutical…
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Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
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China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its novel antiviral drug ziresovir (AK0529). The study evaluated the efficacy and safety of ziresovir in hospitalized infants with respiratory syncytial virus (RSV) infection. The drug achieved its primary endpoint of a significant reduction in symptom…
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Pfizer’s Talzenna Shows Positive Results in Phase III TALAPRO-2 Study for mCRPC
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2 study for its oral poly ADP ribose polymerase (PARP) inhibitor, Talzenna (talazoparib). The study evaluated the drug in combination with Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with or without homologous…
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Hua Medicine’s Dorzagliatin Approved in China for Type 2 Diabetes
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China-based Hua Medicine (HKG: 2552) has announced that its Category 1 drug dorzagliatin has been approved by the National Medical Products Administration (NMPA) for improving blood glucose control in adults with type 2 diabetes. The first-in-class oral hypoglycemic drug represents an innovative treatment option for patients in China. Approval Based…
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Allergan Aesthetics Launches Juvederm Volite in China’s Boao Lecheng
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Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has announced the commercial launch of Juvederm Volite at the Arsmo (Hainan) Aesthetic Hospital in Boao Lecheng, China. The product follows the successful introduction of Juvederm Volux into the region under the “first pilot, first trial” policy, further expanding the company’s aesthetic portfolio…
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Shanghai Lange Medtech Partners with Yantai Desheng for Fish-Derived Rotator Cuff Patch
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China-based Shanghai Lange Medtech Co., Ltd. has entered into a partnership with compatriot firm Yantai Desheng Marine Biotechnology Co., Ltd. to develop a fish-derived rotator cuff biological patch. The collaboration will also focus on constructing the largest fish-derived acellular matrix preparation technology platform in China and advancing clinical and scientific…
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Roche Boosts China Investment with Additional RMB 250 Million
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Swiss pharmaceutical giant Roche (SWX: ROG) has pledged to invest an additional RMB 250 million (USD 35.1 million) in China, underscoring its commitment to the market despite challenges posed by the COVID-19 pandemic. The announcement was made during the 34th International Business Leaders’ Advisory Council for the Mayor of Shanghai.…
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Boston Scientific Launches Disposable RF Electrode for Chronic Pain in China
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Boston Scientific Corporation (NYSE: BSX), a US-based medical device company, has announced the official market launch of its disposable injectable radiofrequency (RF) electrode, the Unified Electrode, in China. The product is designed for the treatment of chronic pain and peripheral neuropathy-related diseases. Market Need and InnovationStatistics indicate that China has…
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Rundo Med-Tech Partners with Baidu to Advance Digital Clinical Trials
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Shanghai-based Contract Research Organization (CRO) Rundo Pharmaceutical R&D (Shanghai) Co., Ltd (Rundo Med-Tech) has entered into a partnership with China Internet giant Baidu to accelerate the development of digitalized smart clinical studies. The collaboration aims to leverage advanced technology to enhance the efficiency and quality of clinical research. Financial details…
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China’s NMPA Releases 60th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 60th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 75 specifications, with 18 specifications undergoing modifications due to increases in marketing authorization holders (MAH) or changes to unlimited trade names. Details of the ReleaseThe release…
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China Medical System Licenses Botulinum Toxin from South Korea’s BMI Korea
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China Medical System Holdings (CMS; HKG: 0867) has announced the establishment of a licensing agreement with South Korea-based BMI Korea Co., Ltd. The agreement grants CMS exclusive development, regulatory filing, importing, and commercialization rights to BMI’s injectable botulinum toxin type A 100U freeze-dried powder in mainland China, Hong Kong, and…
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Junshi Biosciences Launches PD-1 Inhibitor Tuoyi for Advanced NSCLC in China
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Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market launch meeting for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in China. The drug received its sixth indication approval last month for treating…
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Betta Pharmaceuticals Raises $140.5M for Drug Industrialization Base in Zhejiang
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China’s Betta Pharmaceuticals Co., Ltd. (SHE: 300558) plans to raise RMB 1 billion ($140.5 million) through a private placement of 25,967,281 shares at RMB 38.51 ($5.41) per share. The shares will be issued to Ding Lieming, the company’s legal controller. The proceeds will be used to construct a novel drug…
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China’s Volume-Based Procurement Cuts High-Value Medical Consumables Costs by 84%
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The national high-value medical consumables alliance procurement office has released the results of the third round of volume-based procurement (VBP) for high-value medical consumables. A total of 152 manufacturers won the bids, with an average price cut of 84%. This will save approximately RMB 26 billion ($3.65 billion) in medical…
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Everest Medicines’ Xerava Approved in Hong Kong for Complicated Intra-Abdominal Infections
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Everest Medicines Limited (HKG: 1952), a China-based biopharmaceutical company, has announced that it has received market approval from the Department of Health of the Hong Kong Special Administrative Region for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in the…
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Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
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Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). Phase II Clinical Trial DesignThe…
