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Pharmaceutical
GLP1 receptor agonists (GLP1RA) are known as diabetes treatments, but recently they have also doubled as the new generation drugs for overweight/obesity. 5 June 2023
Biotechnology
Japanese drugmaker Chugai Pharmaceuticals has decided to invest over 50 billion yen ($356 million) in total for two new manufacturing facilities at the Utsunomiya plant. 31 May 2023
Biotechnology
Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). 26 May 2023
Pharmaceutical
Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorization application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). 26 May 2023
Biosimilars
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
Pharmaceutical
Japanese drugmaker Daiichi Sankyo today announced that Vanflyta (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive, with the news surprisingly pushing the firm’s shares down 4.4% to 4,582 yen 25 May 2023
Pharmaceutical
Prime Minister Fumio Kishida has announced the government of Japan's pledge to contribute $200 million to the Global Health Innovative Technology Fund (GHIT Fund). 25 May 2023
Pharmaceutical
South Korea’s HanAll Biopharma dipped more than 3% to 21,850 won yesterday, after it announced mixed results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept. 20 May 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder, for priority review. 17 May 2023
Biotechnology
Chinese biotech start-up LaNova Medicines revealed it has entered into an exclusive license agreement with UK pharma major AstraZeneca, for LM-305, a pre-clinical stage antibody drug conjugate (ADC) targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D). 15 May 2023
Pharmaceutical
Following a regulatory update, Japanese speciality pharma company Kyowa Kirin has announced it will pull the plug on its small molecule bardoxolone methyl. 12 May 2023
Pharmaceutical
Following a positive vote last month from the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee, the US Food and Drug Administration (FDA) has now approved the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. 11 May 2023
Biotechnology
Privately-held Chinese biotech Zion Pharma revealed that Swiss pharms giant Roche has acquired the global rights to Zion’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor targeting the human epidermal growth factor receptor 2 (HER2). 10 May 2023
Biotechnology
Risk control was a major topic at the DJSeedin innovation partnering event held on last month in Shanghai as Chinese biotechs are seeking more licensing deals and partnerships to survive in tmpetition in China. 4 May 2023
Biotechnology
Privately-held Australian biotech Cartherics has granted Shunxi Holding Group a license to develop, manufacture and commercialize its autologous CAR-T cell product, CTH-004, for multiple solid tumors including ovarian cancer in Greater China. 28 April 2023
Pharmaceutical
When it comes to getting a novel foreign-made treatment into China as quickly as possible, companies should also look into the local policies in some high-profile special zones. 27 April 2023
Biotechnology
When it comes to expensive treatments such as cell therapy, companies usually do not wish to cut price heavily to join China’s national drug procurement scheme (NDPS). Rather, they have been actively looking for some intriguing, alternative opportunities, said speakers at DJSeedin innovation partnering conference held on April 20 in Shanghai. 24 April 2023
Biotechnology
Biotech investors are cautiously optimistic about opportunities in China in 2023, and they are looking for novel or value-added assets only, said investors at the CMAC conference held in Suzhou in earlier this month. 19 April 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for Lonsurf (trifluridine/tipiracil), Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, have revealed. 19 April 2023
Biosimilars
A lot of topics were discussed at the 2023 China innovative medicine (device) medical conference (CMAC) held in Suzhou on April 7. Among them were real world studies, medical affairs and how to use AI to speed up discoveries. But one most talked about was the challenges for Chinese biotechs to go global. 13 April 2023
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
Pharmaceutical
Big pharmas are not deterred by China’s increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. 18 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
Chinese biotech Keymed Biosciences has entered an exclusive licensing agreement with Platina Medicines for its bispecific antibody candidate, CM336. 18 November 2024
Pharmaceutical
In yet another sign of the mounting interest in radiopharmaceuticals, Tongrui Biopharma, a Chinese innovator in this area, has announced the completion of a $100 million series A+ financing round. 18 November 2024
Biotechnology
Shanghai-based biopharma Zai Lab has announced the pricing of its underwritten public offering at $25.50 per share, aiming to raise around $200 million. 15 November 2024
Biosimilars
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Biotechnology
Merck & Co has entered into an exclusive global license to develop, manufacture and commercialize LM-299 from China-based clinical-stage biotech LaNova Medicines, bringing the US pharma giant into the newly attractive PD-1/VEGF bispecific antibody space. 15 November 2024
Biotechnology
Japanese drugmaker Nippon Shinyaku and USA-based Atsena Therapeutics have entered into an exclusive license agreement for the commercialization of ATSN-101 in the USA and Japan for advancing Atsena’s first- in-class, investigational gene therapy ATSN-101 for Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). 13 November 2024
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