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CDE Releases 60th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 60th batch of chemical generic reference preparations, adding 93 new specifications. The public feedback deadline for this batch is July 18, 2022. Batch DetailsIn this batch, 49 specifications had their information updated. However, 16 specifications failed the review process due to…
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Beijing Tianshi Tongda Raises RMB 140M for Autoimmune Disease Therapies
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China-based Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd has reportedly raised RMB 140 million (USD 20.9 million) in an angel financing round. The round was led by Emerging Technology Partners (ETP) and Redhill Capital, with contributions from CASI Pharmaceuticals Inc. (NASDAQ: CASI). The proceeds will be used for a clinical…
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Wuhan YZY Biopharma Raises RMB 200M for Bispecific Antibodies and COVID-19 Vaccine Development
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China-based Wuhan YZY Biopharma Co., Ltd has reportedly raised RMB 200 million (USD 29.8 million) in a pre-Series C financing round led by Wuhan Hi-Tech, Hubei Science Technology Investment, and Optics Valley Financial Holding. The proceeds will be used for the clinical development of bispecific antibodies (BsAbs) and COVID-19 vaccines,…
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Shandong Xinhua Pharmaceutical Inks Tech Transfer Deal for LXH-2201 with IMM
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China-based Shandong Xinhua Pharmaceutical Co., Ltd (HKG: 0719) has signed a technology transfer agreement with the Institute of Materia Medica (IMM) of the Chinese Academy of Medical Science (CAMS) regarding LXH-2201. LXH-2201 is a Category 1 drug being developed to treat cardiovascular diseases and has completed both pre-clinical and Phase…
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Shionogi Files NDA for S-217622 COVID-19 Antiviral Drug in China
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Japan-based Shionogi & Co., Ltd has submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China for its oral antiviral drug S-217622, developed through a joint venture with Ping An Life Insurance Company under the name Ping An-Shionogi Co., Ltd. Drug ProfileS-217622 is an oral…
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InnoCare Pharma’s ICP-490 Receives NMPA Approval for Hematological Malignancies
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Beijing InnoCare Pharma (HKG: 9969) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its targeted protein degrader ICP-490. The drug is approved for use in multiple myeloma (MM), non-Hodgkin lymphoma (NHL), and other hematological malignancies. Drug ProfileICP-490, developed through InnoCare’s molecular glue…
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Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma
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The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA – targeted chimeric antigen receptor (CAR) T cell therapy and Novartis’ Zolgensma (OAV101) have been awarded breakthrough therapy designations (BTDs). Hrain Bio’s BCMA CAR – T cell is indicated for relapsed / refractory multiple myeloma. The…
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Techbank Medical Closes RMB 100M Series A to Build Global Innovation Platform
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Shanghai Techbank Medical Technology Co., Ltd, a cardiovascular device maker, has reportedly closed its Series A financing round at upwards of RMB 100 million (USD 14.9 million), co – led by Puhua Capital and Hainan Qishen Venture Capital. The proceeds will go towards the establishment of its global medical device…
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PackGene and Genemagic Partner on AAV Production and CDMO Services
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China-based PackGene LLC has entered into a partnership with compatriot firm Genemagic Biosciences Co., Ltd. Under the agreement, PackGene will provide Genemagic with Contract Development and Manufacturing Organization (CDMO) services for the large-scale production of adeno-associated virus (AAV). In return, Genemagic will assist PackGene in enhancing its π-beta SF9 AAV…
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PersonGen BioTherapeutics’ TAA06 Receives Clinical Trial Approval for B7-H3 CAR-T Therapy
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The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06, an in-house developed chimeric antigen receptor (CAR)-T cell targeting B7-H3, has obtained tacit clinical trial approval for relapsed/refractory neuroblastoma. This approval signifies that the world’s first B7-H3 CAR-T therapy will enter the regulatory study phase.…
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Akeso Biopharma’s Cadonilimab Achieves National Delivery in China
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China-based biotech Akeso Biopharma (HKG: 9926) announced the national delivery of its cadonilimab (AK104), marking a commercial launch just six days after approval. The drug, conditionally approved in China on June 29th, is a self-discovered bispecific antibody (BsAb) indicated for the treatment of recurrent or metastatic cervical cancer that has…
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Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
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The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV: SOBIN) market filing for its anakinra (trade name: Kineret) has been prioritized for review. The drug is indicated for autoinflammatory periodic fever syndrome (familial Mediterranean fever – FMF) in adults, adolescents, children, and infants eight…
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Arctic Vision Enrolls First Patient in ARVN003 Phase III Trial for Presbyopia
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China-based ophthalmic therapies developer Arctic Vision announced the first patient enrollment in a Phase III clinical study for its ARVN003, a proprietary pilocarpine formulation leveraging its micro-dosing platform Optejet. The study aims to evaluate the efficacy and safety of ARVN003 in temporarily improving vision in adults with presbyopia (long-sightedness) in…
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WuXi Biologics’ MFG14 Facility Approved for Microbial Product Manufacturing
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) announced that its MFG14 facility in Hangzhou has been released for manufacturing microbial-derived products. The facility has been successfully performing Chemistry, Manufacturing, and Controls (CMC) projects for multiple clients since early 2022, demonstrating the company’s capability to provide…
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JW Therapeutics Initiates Phase I Study of JWATM204 for Hepatocellular Carcinoma
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China-based JW Therapeutics (HKG: 2126) announced the initiation of a Phase I clinical study for its JWATM204 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study aims to evaluate the safety, tolerability, dose-limiting toxicity, and pharmacokinetic profile of JWATM204 in adult subjects with advanced HCC. It will also explore…
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GenScript Biotech’s ProBio Subsidiary Receives USD 37.25M Investment from Zhenjiang Gaoxin
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Hong Kong-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) announced that Zhenjiang Gaoxin Venture Capital Co., Ltd, a wholly-owned subsidiary of state-owned Jiangsu Hanrui Investment Holdings Co., Ltd, is set to acquire 57.31 million Series B preferred ProBio shares for a consideration of USD 37.25 million. The proceeds…
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Zhiyi Bio Raises RMB 100M in Series B++ Round for LBP Pipeline Development
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China-based leading live biotherapeutics (LBP) company Guangzhou Zhiyi Biotechnology Co., Ltd has recently raised RMB 100 million (USD 14.93 million) in a Series B++ financing round. The round was led by SDIC Venture Capital, Guangzhou Development District Investment Group, and Guangzhou Helichuangxing Group Co., Ltd. The proceeds will be used…
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Brii Biosciences Exercises Option for VIR-3434 in Greater China
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China-based Brii Biosciences Limited (HKG: 2137) announced the exercise of its option to acquire exclusive development and commercialization rights for VIR-3434 (BRII-877) in Greater China as part of its broader collaboration with Vir Biotechnology, Inc. (NASDAQ: VIR). Drug ProfileVIR-3434, an investigational subcutaneously administered HBV-neutralizing monoclonal antibody, is designed to block…
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Innovent Biologics Doses First Patient in IBI112 Phase II Study for Ulcerative Colitis
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the successful first patient dosing in a Phase II clinical study (clinicaltrials.gov: NCT05377580) for its IBI112, a recombinant anti-interleukin 23p19 subunit antibody, in moderate-to-severe active ulcerative colitis (UC). The multi-center, randomized, double-blind, parallel, placebo-controlled Phase II clinical study aims to evaluate the efficacy,…
