Your cart is currently empty!
•
Changchun High & New Technology Industries (Group) Inc., a Chinese corporation listed on the Shenzhen Stock Exchange (SHE: 000661), has received tacit approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 biologic product, GenSci098. This humanized anti-TSHR antagonistic monoclonal antibody (mAb)…
•
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 603392), has announced that the National Medical Products Administration (NMPA) has accepted for review the market approval filing for its innovative recombinant human papillomavirus (HPV) vaccine. This nine-valent vaccine, which targets HPV…
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its novel compound BGB-16673. This investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), known as a proteolysis-targeting chimera (PROTAC) product, represents…
•
The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
•
The U.S. Food and Drug Administration (FDA) has granted approval to two updated mRNA COVID-19 vaccines in anticipation of the winter season. Pfizer/BioNTech and Moderna have both received authorization for their vaccines, which are designed to address the KP.2 variant of the virus, a subset of the omicron strain. The…
•
Shouyao Holdings (Beijing) Co., Ltd, a biopharmaceutical company headquartered in Beijing and listed on the Shanghai Stock Exchange (SHA: 688197), has announced that it has obtained clinical trial approval for its drug candidate SY-7166 for the treatment of multiple myeloma (MM) as a monotherapy. SY-7166 is a highly potent and…
•
Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly preparing to submit its dengue fever vaccine for regulatory approval in the United States, according to the Nikkei Asian Review. At this juncture, specifics regarding the timing of the filing or the anticipated decision date…
•
Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
•
Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
•
Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301 to the first patient with late-onset Pompe disease (LOPD) in a regulatory study in China. This marks the nation’s first patient dosing of an adeno-associated virus (AAV) gene therapy for LOPD. GC301 is an innovative…
•
Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has declared the successful completion of a Phase I clinical trial for its OAB-14 drug candidate in a dry suspension formulation. Following the positive outcome, the company is now gearing up to initiate a Phase IIa…
•
Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board (SHA: 688799), has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, ZG-002. This new molecule is intended for…
•
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab), a co-developed Alzheimer’s disease drug by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB). This development, however, was met with a refusal from the National Institute for Health and Clinical Excellence (NICE), the…
•
Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
•
Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
•
CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation from the US Food and Drug Administration (FDA) for its drug candidate Halneuron, which contains tetrodotoxin, for the treatment of chemotherapy-induced neuropathic pain (CINP). Halneuron is an innovative injectable form of tetrodotoxin, a naturally occurring…
•
Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
•
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…