-
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…
-
CDE Releases Guidelines for Clinical Trials of Stem Cell Therapies and Derived Products
•
The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial Techniques for Human-Derived Stem Cells and Derived Cell Therapy Products,” which are now in immediate effect. These guidelines focus on clinical trials for stem cell-related products that are potential candidates for product approval, distinguishing them…
-
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…
-
CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
•
The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates” and is soliciting public feedback until July 21, 2023. The document primarily addresses the technical requirements during the market approval filing stage for antibody drug conjugate (ADC)…
-
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…
