CPhI data confirms that Japan continues to top global active pharmaceutical ingredients ‘API quality’ rankings, with Japanese respondents bullish on growth in 2022 and forecasting a compound annual growth rate (CAGR) of 14% on average. 11 March 2022
Immune checkpoint inhibitors (ICIs) have been approved across an increasing number of oncology indications in China, many of them developed by Chinese companies. 10 March 2022
The life sciences division of tech major NEC Corporation has bought immuno-oncology assets from Swiss-German biotech Vaximm, for an undisclosed amount. 8 March 2022
Japanese drug major Chugai Pharmaceutical Chugai has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW), for approval of an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab), intravenous infusion 1000mg (genetical recombination)] for the treatment of chronic lymphocytic leukemia (CLL). 7 March 2022
Japanese pharma major Shionogi today announced the interim report of a Phase II/III additional dose clinical trial of S-268019, a preventive vaccine for COVID-19. 4 March 2022
Setting aside trouble gaining market access for the newly-approved Aduhelm (aducanumab), Eisai and Biogen continue to pursue early registration of their next-generation Alzheimer’s med. 4 March 2022
Danish allergy immunotherapy specialist ALK Abello said today that it expects to submit a registration application in China for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet already in 2022. 3 March 2022
Japanese companies JCR Pharmaceuticals and Sumitomo Dainippon Pharma have agreed a marketing alliance for the Fabry disease treatment agalsidase beta BS IV infusion at 5mg and 35mg in Japan. 2 March 2022
Taiwanese generics and biosimilar drugmaker Lotus Pharmaceutical has received approval for its abbreviated new drug application (ANDA) in the Philippines for its generic versions of Bristol Myers Squibb’s Revlimid (lenalidomide) and AstraZeneca’s lung cancer drug Iressa (gefitinib). 2 March 2022
South Korea’s GC Pharma saw its shares fall 6.2% to 182,000 won, after it revealed it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its Biologics License Application (BLA) for Alyglo (immune globulin intravenous (human), 10% liquid). 28 February 2022
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant (emapalumab) to the National Medical Products Administration of China (NMPA). 25 February 2022
The World Health Organization (WHO), the Republic of Korea and the WHO Academy have established a global biomanufacturing training hub that will serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments. 24 February 2022
Japanese drugmaker Ono Pharmaceutical says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma. 21 February 2022
South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022
Chinese biopharma firm Innovent Biologics has announced that its experimental anti-PCSK9 antibody, named IBI306, has come up trumps in two Phase III trials in China. 18 February 2022
China-based biotech BeiGene today announced that BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 17 February 2022
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