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Yifan Pharmaceutical’s F-652 Cleared for Phase II Trial in Alcoholic Hepatitis
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary Evive Biotech Ltd’s F-652 has been cleared to start a Phase II clinical trial for a new indication by China’s National Medical Products Administration (NMPA). The trial will assess F-652 as a treatment for alcoholic hepatitis (AH). Mechanism…
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BioNTech Acquires Global Rights to OncoC4’s Anti-CTLA-4 Antibody ONC-392
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Germany-based mRNA specialist BioNTech SE (NASDAQ: BNTX) has unveiled a licensing deal and collaboration with US-based biotech OncoC4, securing global development and commercialization rights to OncoC4’s anti-CTLA-4 antibody ONC-392. Under the terms of the agreement, BioNTech will pay OncoC4 USD 200 million upfront, with further undisclosed development and commercial milestone…
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Cygnus Bio Raises Millions in Series C+ Financing for Sequencing Technology
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Beijing-based second-generation sequencing technology platform Cygnus Bio has reportedly raised “hundreds of millions” of renminbi in a Series C+ financing round. The round was led by Source Code Capital, with contributions from CCB Private Equity Investment, E-town Capital, Founder H Fund, and Lotus Lake Capital. The funds will be used…
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L&L Biopharma Completes Series B Financing for Tumor Immunotherapy Development
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Shanghai-based tumor immunotherapy developer L&L Biopharma Co., Ltd has announced the completion of a Series B financing round, led by Hongfeng Venture. Additional investors included Oriental Wisdom Capital, Zhongchuang Yongjian (Ningbo) Venture Capital, and existing investor Qiao Jing Capital. The funds will be directed towards Phase I clinical studies for…
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T&L Biotechnology Secures RMB 100 Million in Series A Financing
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Beijing-based cell and gene therapy (CGT) developer T&L Biotechnology Co., Ltd has reportedly raised RMB 100 million (USD 14.53 million) in a Series A financing round. The round was led by Harvest Capital and Fortune Capital, with participation from Zhiheng (Yantai) Entrepreneurship Service Center. The funds will be used to…
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Yiling Pharmaceutical’s BIO-008 Receives NMPA Approval for Clinical Trials
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel biologic product BIO-008. This marks a significant milestone in the development of the company’s innovative therapeutic biologic. Development and IndicationsBIO-008 is a monoclonal antibody…
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Hengrui Pharmaceuticals’ SHR8028 Receives NMPA Review for Dry Eye Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing for SHR8028, an anti-inflammatory and immunomodulatory agent under development to treat dry eye, has been accepted for review by the National Medical Products Administration (NMPA) in China. Clinical Study and ResultsThe filing is based on…
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LBX Pharmacy Partners with Gilead Sciences to Enhance Disease Management in China
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China-based LBX Pharmacy has entered into a partnership with US-based Gilead Sciences, Inc (NASDAQ: GILD). The collaboration will focus on channel building, chronic disease compliance, member and private domain traffic management, and access to innovative drugs. Gilead aims to leverage LBX’s extensive network of over 10,000 drugstores, chronic disease and…
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Jiangsu Recbio’s ReCOV Vaccine Receives Emergency Use Authorization in Mongolia
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced that it has received Emergency Use Authorization (EUA) from Mongolia for its ReCOV, a recombinant COVID-19 vaccine co-developed by the Chinese Academy of Sciences. This authorization marks a significant milestone in the global distribution and accessibility of the…
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WuXi AppTec Reports 71.8% Revenue Growth in 2022 Financials
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China-based WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359) released its 2022 financial report, recording revenues of RMB 39.355 billion (USD 5.72 billion), a 71.8% increase year-on-year (YOY). Net profits also grew significantly, reaching RMB 8.814 billion (USD 1.28 billion), up 72.9% YOY. This marks a substantial milestone in the…
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Luye Pharma’s BA1102 Biosimilar to Xgeva Accepted for CDE Review
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China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing for its subsidiary Shandong Boan Biotechnology Co., Ltd’s BA1102, a biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), has been accepted for review by the Center for Drug Evaluation (CDE). Indications and Market ContextDenosumab is a monoclonal…
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Bayer’s Nubeqa Receives Additional NMPA Approval for mHSPC Treatment-Fineline Info & Tech
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German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to…
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NMPA Denies Market Approval for Hengrui’s Plinabulin in Chemotherapy-Induced Neutropenia
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) announced in a stock exchange statement that the National Medical Products Administration (NMPA) has declined to issue a market approval for plinabulin, a potential first-in-class GEF-H1-targeted small-molecule drug in-licensed from US-based BeyondSpring Inc. (NASDAQ: BYSI). Hengrui was seeking approval for the drug’s use…
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SciClone Pharmaceuticals’ Vaborem Approved for Phase III Clinical Trial in China
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that a clinical trial filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been approved by the National Medical Products Administration (NMPA). This approval allows the drug to enter a Phase III clinical study in China. Study Objectives and DesignThe Phase…
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Janssen Withdraws Carvykti from UK Market Amid Manufacturing Concerns
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US-based Janssen Pharmaceutical reportedly decided to withdraw Carvykti (ciltacabtagene autoleucel; cilta-cel) from the UK market last week. The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, which is under development globally by Janssen in partnership with China-based Legend Biotech (NASDAQ: LEGN), was being assessed by the UK’s National Institute of…
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BeiGene Declines Option for Leap Therapeutics’ DKN-01 Development Rights in Asia
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US-based Leap Therapeutics Inc. (NASDAQ: LPTX) announced last week that China-based BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) had declined to exercise its option to take up development and commercial rights in Asia for DKN-01, Leap’s anti-Dickkopf-1 (DKK1) monoclonal antibody (mAb). Despite this decision, the two companies will continue…
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Gracell Secures Non-Exclusive License for Cell Therapies from Seagen
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China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) has secured a non-exclusive worldwide license to develop and commercialize up to five cell therapy products from US biotech company Seagen Inc (ETR: PFE). The agreement was finalized on March 8, 2023, just days before Pfizer announced its intention to acquire Seagen for USD…
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Vas Healthcare Raises RMB 100 Million in Angel Financing for Robot Development
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Vas Healthcare, a developer of vascular interventional surgery robots based in Beijing, has reportedly raised RMB 100 million (USD 14.5 million) in an angel financing round. The round was co-led by CAS Investment and Noah Capital. The funds will be used to support technology research and development, new product iteration,…
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Hainan Poly Pharm’s Generic Gadovist Receives FDA Approval for MRI Use
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various…
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Jacobio Pharma’s JAB-24114 Receives CDE Approval for Phase I/IIa Clinical Study
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/IIa clinical study for its in-house developed JAB-24114, a glutaminase enzyme (GUE) inhibitor. This marks a significant step forward in the development of innovative cancer therapies. Mechanism…
