-
VivaVision Biotech and Dragon Sail Pharmaceutical Partner on Ophthalmology R & D
•
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…
-
Junshi Biosciences Receives FDA Approval for PI3K-α Inhibitor RP903 in Breast Cancer Study
•
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…
-
InnoCare Pharma’s Guangzhou Plant Approved for Orelabrutinib Commercial Production
•
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,…
-
Hengrui Medicine’s Generic Tacrolimus Wins NMPA Approval for Transplant Rejection Prevention
•
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…
-
Medtronic Kanghui and Changzhou High-Tech Zone Partner on Science Park
•
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…
-
NHC Releases Technical Guidelines for Drug Clinical Evaluation
•
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…
-
HitGen and Haichang Bio Partner to Develop Anti-Cancer RNAi Drugs
•
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…
-
Hainan Medical Products Administration Issues Guidelines for Imported Drug Management
•
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…
-
Abbisko Therapeutics Doses First Patient in ABSK061 Phase I Study for Solid Tumors
•
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,…
-
Ascletis Pharma Doses First Patient in ASC22 HIV Study with Chidamide
•
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…
-
Fosun Pharmaceutical and ReNeuron Renew CTX Cell Therapy Deal for China
•
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,…
-
Eurofins DiscoverX Opens Shanghai Office to Expand Asia-Pacific Operations
•
California-based Eurofins DiscoverX Products LLC, a manufacturer of drug discovery solutions, announced the opening of an office in Shanghai, China. The establishment of Eurofins DiscoverX (Shanghai) Ltd marks the company’s first direct expansion of its Asia-Pacific operations into the mainland China market. The new office will serve as a base…
-
Solasia Pharma Reduces China Operations, Transfers Drug Rights to Lee’s
•
Japan-based Solasia Pharma KK (TYO: 4597) announced that it will reduce its direct operations in China by transferring all promotion rights for two drugs to its existing partner, Lee’s Pharmaceutical Holdings Ltd (HKG: 0950). The move aims to enhance sales efficiency across the mainland China market. Drugs InvolvedThe two drugs…
-
NMPA Releases Plans to Support HK and Macau Drug, Device Production in Mainland Cities
•
The National Medical Products Administration (NMPA) has released two implementation plans aimed at supporting Hong Kong and Macau drug marketing authorization holders and medical device registrants to produce drugs and devices in nine mainland cities within the Greater Bay Area. These initiatives allow drug Marketing Authorization Holders (MAHs) and device…
-
Bio-Thera Solutions’ BAT8010 Receives NMPA Approval for Solid Tumor Clinical Trials
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2…
-
Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
•
The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer…
-
Burning Rock Biotech Launches PREVENT Study for Early Cancer Detection
•
Chengdu-based medical device firm Burning Rock Biotech Ltd (NASDAQ: BNR) announced the launch of a ground-breaking interventional validation study focused on the application of its early cancer test, OverC, in detecting various cancer types in asymptomatic patients. The PREVENT (Prospective multi-canceR Early-detection and interVENTional) study will enroll 12,500 individuals to…
-
Harbour BioMed’s Partner NK Celltech Raises RMB 100M in Series A Financing
•
China-based Harbour BioMed (HKG: 2142) announced that its strategic partner NK Celltech, a company focusing on NK cell-based cell therapies, has successfully raised over RMB 100 million (USD 14.9 million) in a Series A financing round. The round was led by HUAGAI Capital, with participation from CAS Venture Capital, Qiandao…
-
NMPA Releases 55th Batch of Reference Drugs for Generic Evaluation
•
The National Medical Products Administration (NMPA) has released the 55th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 16 injectables among a total of 78 new specifications. Additionally, 21 specifications saw modifications, including four injectables. Batch DetailsThe latest batch aims to provide updated reference…
-
BeiGene’s Tislelizumab Shows Survival Benefit in Esophageal Cancer Study
•
BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously…
