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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,…
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VivaVision Biotech and Dragon Sail Pharmaceutical Partner on Ophthalmology R & D
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China’s VivaVision Biotech Inc. has entered into a partnership with compatriot firm Dragon Sail Pharmaceutical. Under the agreement, Dragon Sail will support VivaVision’s preclinical pharmaceutical research, ranging from sequence to IND filing, with a focus on eye diseases. Financial details of the deal were not disclosed. Company ProfilesVivaVision is dedicated…
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Junshi Biosciences Receives FDA Approval for PI3K-α Inhibitor RP903 in Breast Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study of its PI3K-α inhibitor RP903 (JS105) in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative, PIK3CA-mutated advanced or metastatic…
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InnoCare Pharma’s Guangzhou Plant Approved for Orelabrutinib Commercial Production
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Beijing InnoCare Pharma (HKG: 9969) announced that as of June 30, its manufacturing plant in Guangzhou has been approved for the commercial manufacturing of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The plant, located in Sino-Singapore Guangzhou Knowledge City, is compliant with Good Manufacturing Practice (GMP) standards in China, Japan,…
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Hengrui Medicine’s Generic Tacrolimus Wins NMPA Approval for Transplant Rejection Prevention
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Astellas’s tacrolimus. The drug is approved for use in the prevention of graft rejection after kidney transplantation, prevention of graft rejection in the…
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Medtronic Kanghui and Changzhou High-Tech Zone Partner on Science Park
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Medtronic Kanghui and Changzhou National High-Tech Industrial Development Zone have agreed to collaborate on the establishment of the “Medtronic Kanghui Changzhou Science and Technology Park.” The initiative aims to enhance regional advanced medical manufacturing capabilities, particularly in the orthopedic industry. Background and Strategic RoleKanghui became a wholly-owned subsidiary of Medtronic…
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NHC Releases Technical Guidelines for Drug Clinical Evaluation
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The National Health Commission (NHC) has released the “Technical Guidelines for Comprehensive Clinical Evaluation of Cardiovascular Drugs,” “Technical Guidelines for Comprehensive Clinical Evaluation of Antineoplastic Drugs,” and “Technical Guidelines for Comprehensive Clinical Evaluation of Children’s Drugs” (all 2022 trial versions), effective as of July 1, 2022. BackgroundThe NHC released the…
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HitGen and Haichang Bio Partner to Develop Anti-Cancer RNAi Drugs
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China-based HitGen Inc. (SHA: 688222) announced the establishment of a strategic partnership with compatriot firm Zhejiang Haichang Biotechnology Co., Ltd, an RNA interference (RNAi) specialist, to develop anti-cancer RNAi drugs. The partnership aims to leverage the strengths of both companies in RNAi drug discovery and delivery systems. Company ProfilesHitGen, focused…
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Hainan Medical Products Administration Issues Guidelines for Imported Drug Management
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The Hainan Medical Products Administration (HMPA) has released a set of guidelines that took effect immediately, providing measures for the management of patients accessing imported drugs through the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone. The guidelines focus on managing patients who travel to Hainan to…
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Abbisko Therapeutics Doses First Patient in ABSK061 Phase I Study for Solid Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the first patient dosing in a Phase I clinical study for its ABSK061, an oral highly selective FGFR2/3 inhibitor, in solid tumors. The molecule is described as the first of its kind globally to reach the clinical stages. Study DetailsThe study,…
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Ascletis Pharma Doses First Patient in ASC22 HIV Study with Chidamide
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China-based Ascletis Pharma Inc. (HKG: 1672) announced that the first patient has been dosed in a clinical study for its PD-L1 antibody ASC22 (envafolimab) in combination with chidamide for the functional cure of human immunodeficiency virus (HIV) infection. The study was initiated by the Shanghai Public Health Clinical Center. This…
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Fosun Pharmaceutical and ReNeuron Renew CTX Cell Therapy Deal for China
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has negotiated a new “supplemental terms agreement” with UK-based partner ReNeuron Group plc (OTCMKTS: RNUGF) worth GBP 6 million (USD 7.3 million). This deal builds on an earlier agreement signed in April 2019, under which Fosun obtained exclusive development,…
