-
Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
•
US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
-
S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
•
S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) for its “human umbilical cord mesenchymal stem cell injection” in the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Product Development and ARDS OverviewThe in-house developed…
-
Kite Pharma’s Yescarta Marketing Rights Transferred to Gilead Sciences K.K. in Japan
•
US immunotherapy specialist Kite Pharma, Inc. has announced that the Marketing Authorization for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. (TYO: 4568) to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc (NASDAQ: GILD). History of Yescarta and…
-
Hopstem Biotechnology’s hNPC01 Receives Tacit Approval for Stroke Sequelae Treatment from CDE
•
Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists from Johns Hopkins University, has announced receiving tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for its hNPC01. This induced pluripotent stem cells (iPSC) derived cell therapy is intended for the treatment…
-
Edding Pharma Aims for Fifth IPO Attempt on Hong Kong Stock Exchange
•
China-based Edding Pharma is gearing up for its fifth attempt to hold an initial public offering (IPO) on the Hong Kong Stock Exchange. The company reported revenues of RMB 2.074 billion (USD 289 million) last year, with net profits reaching RMB 306.3 million (USD 42.67 million), primarily from a portfolio…
-
Sciwind Biosciences Leads China’s Anti-Obesity Drug Market with GLP-1 Analog Ecnoglutide
•
Sino-US biotech Sciwind Biosciences Co., Ltd has positioned itself as a frontrunner in China’s race to market anti-obesity drugs. The company made a significant impact at the American Diabetes Association (ADA) conference with three poster presentations, including a late-breaking presentation, highlighting its glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW003). Ecnoglutide: An…
-
Aureka Biotechnologies Secures $10 Million in Seed Funding for AI-Driven Biotechnology
•
Aureka Biotechnologies Inc., a California-based artificial intelligence (AI)-empowered biotech company, has successfully raised USD 10 million through a seed financing round led by K2 Venture Partners and Newerli Capital, both China-based private equity funds. The funds will be directed towards the research and development of an AI+high-throughput digital biotechnology macromolecular…
-
Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
•
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab from conditional approval to full approval for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with sorafenib or chemotherapy. Camrelizumab’s Approval History and IndicationsCamrelizumab, which received first approval…
-
Biocytogen Pharmaceuticals Receives CNIPA Patent for RenMab Human Antibody Mice Platform
•
China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced receiving a prestigious patent award from the China National Intellectual Property Administration (CNIPA) for its in-house developed human antibody mice RenMab platform. This recognition underscores the company’s commitment to innovation in the field of antibody development. RenMab Technology Platform OverviewThe…
-
BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
•
China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
-
Jiangsu Hengrui Pharmaceutials’ SHR-1209 for Hypercholesterolemia Accepted for NMPA Review
•
China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). The product is intended to treat hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. Phase…
-
Minghui Pharmaceutical Achieves First Dosing Milestone in Phase I Studies for ADC Candidates
•
China-based biotech Minghui Pharmaceutical Inc. has reported that the first dosing has been completed in two Phase I studies assessing the company’s antibody drug conjugate (ADC) candidate drugs, MHB036C and MHB088C. Both candidates are developed on Minghui’s proprietary SuperTopoi platform, with MHB036C targeting TROP2 and MHB088C targeting B7-H3. SuperTopoi Platform…
-
Xiamen ITG Group and Fosun Health Collaborate on Big Health Industry Fund and Medical Device Commercialization
•
China-based Xiamen ITG Group Co., Ltd. (SHA: 600755) and Shanghai Fosun Health Technology (Group) Co., Ltd have announced a strategic partnership to establish a big health industry fund, collaborate on the commercialization of medical devices, and explore the development and application of health big data. While financial details of the…
-
Australian Scleral Lens Epicon A Approved by China’s NMPA as 10th Novel Product
•
Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the National Medical Products Administration (NMPA) in China, marking it as the 10th novel product supported by Lecheng’s real-world data. This Category III medical device is set to make a significant impact on the correction of…
-
CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
•
The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s MIL162 and US firm Amgen’s AMG 890 are on track to receive breakthrough therapy designation (BTD) awards in China. MIL162 is under development as a treatment for primary membranous nephropathy (pMN), while AMG 890 targets…
-
Fujian Cosunter Pharmaceutical’s COVID-19 Drug GST-HG171 Meets Primary Endpoint in Phase II/III Study
•
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III regulatory clinical study for its Category 1 product, GST-HG171/ritonavir, in mild/moderate COVID-19 patients has been unblinded and has successfully reached its primary endpoint. Design and Results of the StudyThe multi-center, randomized, double-blind, placebo-controlled study aimed…
-
Boehringer Ingelheim’s Spevigo on Track for Priority Review for GPP Flare Prevention in China
•
Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form, is poised for priority review status in China. This recognition from the Center for Drug Evaluation (CDE) is attributed to its potential use in preventing flares in generalized pustular psoriasis (GPP), following the molecule’s earlier…
-
Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
•
Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has been approved to enter clinical trials for the treatment of cervical cancer in China. The molecule will be assessed in combination with platinum chemotherapy and with or without bevacizumab, as per the Chinese firm’s announcement.…
-
Pfizer to Establish Smart Medical Innovation Center in Hangzhou’s Qiantang District
•
US pharmaceutical giant Pfizer (NSE: PFIZER) has announced a plan to establish a smart medical innovation center in the Qiantang district of Hangzhou city in China. This initiative aims to bolster the Chinese medical industry’s digital innovation capabilities and contribute to the advancement of healthcare solutions in the region. Empowering…
-
Medivir AB Receives Chinese Patent Approval for Liver Cancer Treatment Fostroxacitabine Bralpamide
•
Sweden-based Medivir AB (FRA: MVR0) has announced the approval of a patent in China for its fostroxacitabine bralpamide (fostrox) and its use in the treatment of liver cancer. The patent, which remains valid until 2035 with potential for extensions, is a significant milestone for Medivir, considering China’s large population of…
