Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
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
Chinese contract research, development and manufacturing organization (CRDMO) WuXi Biologics has announced a 10-year, $1.4 billion investment plan to expand its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore. 19 July 2022
Japanese drugmaker Daiichi Sankyo today announced today that the US Patent and Trademark Office (PTO) has granted Seagen’s request for rehearing of the decision to institute post-grant review, and therefore decided not to proceed with the post-grant review process in which Daiichi Sankyo was contesting the patentability of certain claims within Seagen’s US patent 10,808,039 (the ’039 patent). 19 July 2022
Japanese drug major Chugai Pharmaceutical’s Chinese subsidiary has launched Edirol (eldecalcitol) in China for the treatment of postmenopausal osteoporosis. 18 July 2022
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
South Korean company LegoChem Biosciences and Germany’s Glycotope have signed a research collaboration and license agreement to develop an antibody drug conjugate (ADC). 12 July 2022
Market expansion services provider DKSH has partnered with life cycle management company Pharmanovia, to bring high-quality pharmaceutical products to patients across the Asia Pacific. 11 July 2022
Japanese drugmaker Mitsubishi Tanabe Pharma is to sell US pharma major Eli Lilly’s diabetes drug tirzepatide in Japan following an agreement between the companies. 8 July 2022
Sino-American company Brii Biosciences announced the commercial launch of the amubarvimab/romlusevimab (previously BRII-196/BRII-198) combination, a long-acting COVID-19 neutralizing antibody therapy, in China. 8 July 2022
China-based WuXi STA, a subsidiary of WuXi AppTec (SHA: 603259), today announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. 7 July 2022
Biotech BeiGene has entered into a worldwide strategic collaboration with InnoRNA, a privately-held LNP-based delivery technology and mRNA drug discovery specialist. 6 July 2022
Japanese drugmaker Eisai’s shares gained almost 6% to 6,167 yen after, along with partner Biogen, it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401). 6 July 2022
Japanese contract development and manufacturing organization (CDMO). Fujifilm Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, has announced the investment of $1.6 billion to enhance and expand its cell culture manufacturing services. 4 July 2022
Japan’s largest drugmaker Takeda has announced late-breaking data from the Phase III SPRING study presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022, demonstrating positive results of Takhzyro (lanadelumab) for preventing hereditary angioedema (HAE) attacks in patients 2 to 1 July 2022
Privately-held US biotech Generian Pharmaceuticals has entered into a collaboration and exclusive license agreement with Japanese drug major Astellas Pharma’s Mitobridge unit, to discover and develop novel small molecules for undruggable therapeutic targets by using a proprietary drug discovery platform for diseases that have limited treatment options. 29 June 2022
invoX Pharma, a wholly-owned subsidiary of Sino Biopharmaceutical that is focused on research and development (R&D) and business development activities outside of China, today announced that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of F-star Therapeutics’ common stock. 23 June 2022
Biotech firm BeiGene said today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. 22 June 2022
Japanese drug major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra (emicizumab [genetical recombination]) for an additional indication of routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A. 22 June 2022