-
Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
-
Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
-
Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
•
Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
-
Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
-
Tonghua Dongbao Pharmaceuticals Commences Phase IIa Trial for Dual-Targeted Gout Drug Candidate
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a China-based pharmaceutical company, has announced that the first patient has been dosed in a Phase IIa clinical study for its dual-targeted drug candidate, THDBH151, which is being evaluated for the treatment of gout. THDBH151 is designed to target both xanthine oxidase (XO) and the…
-
Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
•
Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
-
Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
•
Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic…
-
China’s CDE Gives Tacit Approval to Keymed Biosciences’ Alzheimer’s Drug CM383 for Clinical Trials
•
The Center for Drug Evaluation (CDE) has indicated on its website that China-based Keymed Biosciences Inc. (2162.HK) has received tacit approval for its pipeline candidate drug CM383 to proceed to clinical studies. The monoclonal antibody (mAb) is intended for the treatment of Alzheimer’s disease (AD). CM383 targets amyloid-beta (Aβ), a…
-
EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
•
EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
-
Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
-
Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This approval marks the…
-
HuidaGene’s MECP2 Duplication Syndrome Therapy Earns Positive EMA Opinion
•
HuidaGene (Shanghai) Biotechnology Co., Ltd, a biotech company based in China, has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding its orphan drug filing for HG204. HG204 is an RNA editing therapy developed independently by HuidaGene,…
-
Hansoh Pharmaceutical Secures Exclusive Rights to QYuns Therapeutics’ QX004N in Greater China
•
Jiangsu QYuns Therapeutics Co., Ltd, a biopharmaceutical company based in China, has entered into a partnership with compatriot firm Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) for the development and commercialization of its Category biologic product, QX004N. QX004N is an in-house developed monoclonal antibody (mAb) that specifically binds to IL-23…
-
Jacobio Pharma’s Glecirasib Shows Promise in Phase II Study for NSCLC Presented at ASCO
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced the presentation of results from a Phase II regulatory study for its KRAS G12C inhibitor, glecirasib, at the 2024 American Society of Clinical Oncology (ASCO) Plenary Series. In terms of efficacy, the study reported a confirmed objective response…
-
BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
-
China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
•
Shenzhen Chipscreen Biosciences Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
-
Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
•
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR). The market filing is supported by a Phase…
-
Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
-
Cutia Therapeutics Submits New Drug Application for Androgenic Alopecia Treatment in Hong Kong
•
Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New Drug Application (NDA) for its proprietary CU-40102 (external einasteride spray) for the treatment of androgenic alopecia to the Department of Health of Hong Kong, China. CU-40102 is positioned as the world’s first and currently only…
-
Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
