-
Junshi Biosciences’ JS401 Accepted for Review by China’s NMPA for Hyperlipidemia
•
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for JS401, an injectable co-developed with partner Risen Pharma. The product is an ANGPTL3 mRNA-targeted small interfering RNA (siRNA) designed to treat hyperlipidemia. JS401: Mechanism and DevelopmentJS401 targets…
-
Pfizer Reports Record Revenues as COVID-19 Sales Soar; 2023 Guidance Amid Market Shifts
•
US-based Pfizer Inc. (NYSE: PFE) reported its Q4 2022 financial results, highlighting an all-time high in 12-month revenues of USD 100.3 billion, up 30% year-on-year (YOY) excluding foreign exchange impacts. The company’s COVID-19 portfolio, including the Comirnaty vaccine and Paxlovid treatment, drove significant growth, though Pfizer expects a substantial revenue…
-
Junshi Biosciences Partners with Huahai for Production of COVID-19 Drug VV116
•
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a production and supply agreement between its subsidiary, Shanghai JunTop Biosciences Co., Ltd, and Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521). Under the deal, Huahai will provide manufacturing and supply services for Junshi’s oral nucleoside analog drug JT001 (VV116), which is…
-
Ocumension Completes Enrollment for Global Phase III Study of Myopia Treatment OT-101
•
Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) has announced the completion of enrollment for a global Phase III study of its pipeline candidate OT-101. The randomized, double-blind, placebo-controlled, multi-center trial aims to assess the efficacy and safety of OT-101 in treating myopia in children. The study has enrolled 170 subjects,…
-
R&B Bio Raises RMB 200 Million in Series A+ Round to Advance Gene Therapy Pipeline
•
Chengdu-based gene therapy firm R&B Biotech has reportedly secured over RMB 200 million (USD 29.64 million) in a Series A+ financing round. The round was led by SDIC Venture Capital, with participation from Panlin Capital, Essence Fund’s healthcare fund, and existing investor Loyal Valley Capital. The proceeds will be allocated…
-
Hengrui’s HER2-Targeted ADC SHR-A1811 Gains NMPA Clearance for Clinical Trial
•
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase Ib/II clinical study for its investigational HER2-targeted antibody-drug conjugate (ADC), SHR-A1811. The study will evaluate the drug in patients with unresectable or metastatic breast cancer with low…
-
Hengrui’s Lutetium [177Lu] Oxy-Octreotide Gains Clinical Clearance in China
•
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its lutetium [177Lu] oxy-octreotide. The drug is being developed to treat unresectable or metastatic, progressive, well-differentiated (G1 and G2) neuroendocrine tumors that are somatostatin receptor-positive, specifically targeting gastrointestinal and pancreatic neuroendocrine…
-
Changchun BCHT Gains NMPA Approval for Herpes Zoster Vaccine
•
China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its live attenuated herpes zoster vaccine. The vaccine is indicated for the prevention of herpes zoster in adults aged 40 and above, addressing a significant unmet medical need in…
-
Jemincare’s Avatrombopag Market Filing Accepted for Review by China’s CDE
•
China-based Jiangxi Jemincare Group has announced that its market filing for avatrombopag maleate (20mg) has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for the Category 4 chemical drug to treat chronic liver disease-associated thrombocytopenia (CLDT) in patients undergoing elective diagnostic procedures…
-
Ascletis Receives FDA Approval for Phase IIa Trial of ASC10 in RSV Infection
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to conduct a Phase IIa clinical study for its investigational drug ASC10 in patients with respiratory syncytial virus (RSV) infection. ASC10 is an oral double prodrug designed to be rapidly and completely converted in vivo into…
-
Daewoong Pharmaceutical Licenses Bersiporocin to CSP for Greater China Development
•
South Korea-based Daewoong Pharmaceutical has entered into an exclusive licensing agreement with UK-based CS Pharmaceuticals (CSP) for its first-in-class PRS inhibitor, bersiporocin. Under the agreement, CSP will hold exclusive development and commercial rights to the drug in Greater China, including mainland China, Hong Kong, Taiwan, and Macau. The deal covers…
-
Sirnaomics Accelerates STP705 Development After Positive Skin Cancer Trial Results
•
Sirnaomics Ltd (HKG: 2257) is advancing the clinical development of STP705 following positive results from a Phase IIb study in cutaneous squamous cell carcinoma in situ (isSCC) and a Phase II study in basal cell carcinoma (BCC). The company is actively engaging with the US FDA to finalize the protocol,…
-
Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
•
China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline. BPI-460372: Targeting the Hippo Signaling…
-
Novartis Q4 Results Show Growth in Innovative Medicines Amid Sandoz Spin-Off Plans
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has released its financial results for Q4 and the full-year 2022. Global net sales declined 2% year-on-year (YOY) in US dollar terms but increased 4% in constant currency terms to USD 50.545 billion. In Q4, sales expanded by 3% YOY to USD 12.69 billion.…
-
Zhifei Renews Vaccine Supply Agreement with Merck Sharp & Dohme
•
China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the renewal of a supply, distribution, and co-promotion agreement with Merck Sharp & Dohme (MSD, NYSE: MRK) for the US firm’s vaccine products. Under the renewed agreement, Zhifei aims to secure the supply of MSD’s human papillomavirus (HPV) and pentavalent…
-
Abbott’s Q4 Sales Dip Amid COVID-19 Testing Decline, China Market Updates
•
US-based Abbott (NYSE: ABT) released its Q4 2022 financial results last week, showing a 6.1% year-on-year (YOY) decline in global sales to USD 10.091 billion, excluding foreign exchange impacts. Over the full year, sales increased 6.4% YOY to USD 43.65 billion. Abbott Chairman and CEO Robert B. Ford highlighted the…
-
Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung…
-
Hengrui’s Camrelizumab-Apatinib Combo Approved for Liver Cancer in China
•
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This marks the…
-
Yiling Pharmaceutical’s G201-Na Accepted for Review by China’s NMPA for Prostate Cancer
•
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for G201-Na, a Category 1 chemical being developed to treat prostate cancer requiring androgen castration, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
-
Zhaoke Ophthalmology’s Cyclosporine A Eye Gel Nears Market Approval in China
•
Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced that its cyclosporine A eye gel for dry eye treatment has passed the market filing review and clinical trial on-site inspection by the National Medical Products Administration (NMPA). This milestone brings the firm’s…
