Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint. 17 September 2024
US biotech Capricor Therapeutics has entered into a binding term sheet with Japanese drugmaker Nippon Shinyaku for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel. 17 September 2024
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s 11 September 2024
Detailed results were released from the TROPION-Lung01 Phase III trial, which showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxe. 10 September 2024
Chinese companies Innovent Biologics and GenFleet have recently secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib). 9 September 2024
Summit Therapeutics on Sunday announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab compared to Merck & Co’s) mega blockbuster drug Keytruda (pembrolizumab). 9 September 2024
Organon KK, a Japan subsidiary of Organon & Co, announced that the primary endpoint was achieved in a domestic Phase III clinical trial evaluating the efficacy and safety of OG-8276A 6 September 2024
Targeted alpha therapy (TAT), or radioligand therapy, is a recent hot area that attracted big pharmas like Bristol Myers Squibb and Novartis. 5 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Privately-held Chinese biotech EpimAb Biotherapeutics and Vignette Bio have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06. 5 September 2024
Rigel Pharmaceutical’s shares dipped 4.4% to $12 .85 by late morning, despite announcing what could be a lucrative deal for the company. 3 September 2024
Chinese gene therapy specialist YolTech Therapeutics has entered into an exclusive licensing agreement with Salubris Pharmaceuticals (SHE: 002294). 3 September 2024
Japan’s Nxera Pharma today announced that it will receive a $35 million payment from Neurocrine Biosciences, triggered by the successful completion of the Phase II trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia. 2 September 2024
Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Jacobio Pharma announced that it has granted the China rights to KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals. 2 September 2024
Japanese drugmaker Chugai Pharmaceutical says it will transfer the business of the secondary hyperparathyroidism drug Oxarol for Injection (maxacalcitol) to LTL Pharma in Japan. 29 August 2024
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for tazemetostat for the treatment of adult patients with relapsed or refractory (R/R ) follicular lymphoma (FL) has been accepted for review and granted Priority Review in China. 4 July 2024
China’s Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved Japanese pharma major Astellas’ Xtandi (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 2 July 2024
Japanese drugmaker Eisai today announced it is ending its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC). 1 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024
Japanese drugmaker Shionogi announced that the newly-obtained clinical data for the novel COVID-19 oral antiviral Xocova. (ensitrelvir fumaric acid) 1 July 2024
Japanese drugmaker Eisai and US biotech Biogen (announced that their humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in China. 28 June 2024
UCB ( has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for Briviact (brivaracetam). 26 June 2024
US pharma major AstraZeneca (LSE: AZN) today revealed that its Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan . 25 June 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has approved Crysvita (burosumab) from Japanese drugmaker Kyowa Kirin. 21 June 2024
Spanish plasma-derived products specialist Grifols announced it has completed the sale of a 20% equity stake in Shanghai RAAS (SRAAS) to Haier Group Corp. 20 June 2024
Midsize Japanese drugmaker Otsuka Pharmaceuticals says it has concluded an expanded licensing agreement for hereditary angioedema (HAE) drug candidate donidalorsen with Ionis Pharmaceuticals to cover the development and sales area to the Asia-Pacific region, including Japan. 20 June 2024
The US unit of Japan’s Mitsubishi Tanabe Pharma has announced results from two studies of its already marketed Radicava (edaravone) for amyotrophic lateral sclerosis (ALS) at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 meeting. 18 June 2024
Takeda, Japan’s largest drugmaker, today announced mixed top-line data from its SKYLINE and SKYWAY Phase III trials outcomes for its drug soticlestat. 17 June 2024
German biotech BioNTech today announced that it has been informed by its partner, China’s MediLink Therapeutics (Suzhou), that the US Food and Drug Administration (FDA) has placed a partial clinical hold on a trial of their antibody-drug conjugate (ADC). 17 June 2024
Japanese drugmaker Mitsubishi Tanabe Pharma (MTPC) has entered into an agreement with Paris, France-based Ethypharm for the transfer of the business of the selective antithrombin agent, argatroban monohydrate in Europe. 17 June 2024
At a meeting with Brazil’s Vice President and Minister of Development, Industry and Commerce Geraldo Alckmin, in Beijing, Chinese vaccine developer Sinovac Biotech announced that it will invest $100 million in the development of cell therapy, vaccine production and monoclonal antibodies in Brazil. 17 June 2024