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
Japanese conglomerate Fujifilm Holdings Corporation is to invest a further $1.2 billion to expand its large-scale cell culture CDMO business in North Carolina, USA. 12 April 2024
Antibody drug conjugates (ADCs) are currently in vogue with investors and big pharma, as a rapidly emerging class of therapeutic agents that combine the target specificity of a monoclonal antibody with the lethality of cytotoxic cellular poison. 10 April 2024
Japan-based Teijin Group’s healthcare business, Teijin Pharma, has entered into an exclusive global licensing agreement with French drugmaker Bioprojet Pharma. 10 April 2024
Sino Biopharmaceutical revealed it has entered into a strategic partnership with Boehringer Ingelheim to bring the German family-owned company’s innovative cancer therapies to the market in mainland China. 9 April 2024
An FXR agonist developed by Ascletis Pharma has not performed well in mid-stage trials, leading the Hangzhou, China-based firm to dial down its investment in the drug. 8 April 2024
Two frequent words that people often hear in recent China’s pharma industry comments are “Chu Hai” and “Nei Juan”. The former means “selling overseas,” while the latter means “cut throat competition.” 8 April 2024
The US Food and Drug Administration on Friday granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors. 6 April 2024
In the next decade, Japan’s largest drugmaker Takeda Pharma is hoping to bring more Chinese developed drugs to the global market by working with local partners in some key therapeutic areas, said its leaders at Takeda R&D China innovation forum held in Shanghai. 5 April 2024
Japanese pharma company Nippon Shinyaku and privately-held UK small activating RNA (RNAa) therapeutics specialist MiNA Therapeutics have announced a collaboration. 5 April 2024
UK-based specialty CNS-focused pharma company CNX Therapeutics today announce that it has successfully completed the acquisition of two CNS products from the French sales subsidiary of Japan’s Eisai. 2 April 2024
An additional Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the US Food and Drug Administration. 2 April 2024
Taiho Ventures unit has been selected as a certified venture capital of the Strengthening Program for Pharmaceutical Startup Ecosystem implemented by the Japan Agency for Medical Research and Development (AMED) and has entered into an agreement with AMED. 2 April 2024
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older. 28 March 2024
A South Korean company, AriBio, has announced the signing of exclusive marketing rights for its investigational Alzheimer’s disease drug, AR1001. 27 March 2024
UK pharma major AstraZeneca’s shares edged up 1% to 10,550 pence in early trading, as the company announced receipt of two approvals from the Japanese medicines regulator. 27 March 2024