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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…
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Hengrui Pharmaceuticals’ Dexmedetomidine Nasal Spray Approved by NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its dexmedetomidine hydrochloride nasal spray (1ml:500μg). The drug is approved for use as a preoperative sedation in adults. History and Innovation of DexmedetomidineDexmedetomidine was first applied…
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Asiflyer Bio Raises Millions in Pre-Series A Funding for Botox and ZFP Technology
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Shanghai-based recombinant protein drug developer Asiflyer Bio has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by DNE Capital, with participation from Yuanbio Venture Capital, its angel financing investor. The funds will be used to advance the industrialization of the fourth-generation…
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Tot Biopharmaceutical Terminates Phase III Study for HER2-Targeted ADC TAA013
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Tot Biopharmaceutical International Co., Ltd (HKG: 1875) has announced the termination of the Phase III clinical study for its HER2-targeted antibody-drug conjugate (ADC) TAA013. The decision was made due to significant changes in the market competitive landscape for the drug target and technology. Rational Resource Allocation and Strategic TransformationThe China-based…
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Shouyao Holdings Receives CDE Approval for Phase II Study of Third-Generation ALK Inhibitor
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. The study will focus on patients with ALK gene fusion-positive advanced non-small cell lung cancer (NSCLC) who…
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Enlight Medical Technologies to Acquire Synexmed, Expand Vascular Intervention Capabilities
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China-based Enlight Medical Technologies (Shanghai) Co., Ltd is set to fully acquire Japanese firm Japan Lifeline’s (TYO: 7575) China unit Synexmed (Shenzhen) Co., Ltd for an undisclosed amount. This acquisition will enhance Enlight’s capabilities in the vascular intervention market. About Synexmed and the AcquisitionFounded in 2005, Synexmed specializes in supplying…
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Likang Life Sciences’ Personalized Neoantigen Vaccine LK101 Receives IND Approval
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Likang Life Sciences has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its LK101, a personalized neoantigen-targeted vaccine. This marks the first personalized neoantigen vaccine and mRNA editing product to be approved for clinical trials by the NMPA. LK101 will…
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AffaMed Technologies’ EDOF Intraocular Lenses Receive FDA Approval in Taiwan
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced that it has received market approvals from the Taiwan Food and Drug Administration for its MINI WELL, MINI WELL PROXA, and MINI WELL TORIC intraocular lenses, as well as the monofocal intraocular lens MINI 4 Ready. These…
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Walvax Biotechnology Announces Positive Results for RQ3013 mRNA Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the safety, immunogenicity, and protective efficacy results of a Phase IIIb clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The vaccine was co-developed by Shanghai Llanque Biomedical Co., Ltd and…
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AIM Vaccine Initiates Phase I Clinical Study for MCV4 Meningococcal Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the initiation of a single-center, open Phase I clinical study for its ACYW135 meningococcal polysaccharide conjugate vaccine, MCV4. The study is expected to enroll 120 subjects, marking a significant step in the development of this vaccine. Market Context and CompetitionCurrently, commercially…
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Bochuang Biotechnology Secures Angel Funding for High-Purity Collagen and Innovative Medical Product Development
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Jiangsu Bochuang Biotechnology Co., Ltd reportedly secured an undisclosed amount of funding in an angel financing round led exclusively by Dalton Venture. The proceeds will be utilized for the extraction of high-purity active collagen, the in-depth development of oral bone tissue-guided membrane adhesive and artificial cornea, and the establishment of…
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NMPA Accepts Market Filing for Guangdong Zhongsheng’s COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that the market filing for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step towards the potential commercialization of the drug for COVID-19…
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Mabwell Bioscience’s 9MW3811 Gains NMPA Approval for Clinical Trials in China
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb). The drug is intended for the treatment of various advanced malignant tumors and fibrotic diseases. It…
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Everest Medicines’ Xerava Receives NMPA Approval for Complicated Intra-Abdominal Infections
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China-based Everest Medicines Limited (HKG: 1952) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in China, with plans to commercialize the product during the…
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Terumo Blood and Cell Technologies Partners with EurekaBio to Establish Cell Therapy Lab
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US-based Terumo Blood and Cell Technologies has entered into a partnership with Shenzhen-headquartered EurekaBio Technology to jointly establish a cell therapy process development platform laboratory. The collaboration aims to advance innovations in cell therapy, although no financial details were disclosed. About Terumo Blood and Cell TechnologiesTerumo Blood and Cell Technologies…
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Fosun Pharma’s Generic Remodulin Gains NMPA Approval for Pulmonary Arterial Hypertension
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its generic version of Remodulin (treprostinil) has been approved by the National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH). The drug is marketed to alleviate symptoms caused by exercise. Understanding PAH and…
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RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
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China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase I/IIa study. The study will assess the safety, tolerability, pharmacokinetics, and efficacy of RC88 combined with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab),…
