An increase in demand for Active Pharmaceutical Ingredients (APIs) from India is a result of increasing customer diversification away from China, with some countries adopting a 'China plus one' policy. 7 January 2021
Japanese drugmaker Daiichi Sankyo says it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for teserpaturev (G47∆), an oncolytic virus, for the treatment of patients with malignant glioma. 5 January 2021
A COVID-19 vaccine developed by an affiliate of state-backed pharmaceutical firm Sinopharm was approved for widespread use in China on Thursday, it has been widely reported. 31 December 2020
Hutchison China MediTech, a Chinese company also known as Chi-Med, has announced that surufatinib has been granted approval for the treatment of non-pancreatic neuroendocrine tumors (NETs) in its home country. 30 December 2020
Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers, the drug’s developers announced on Monday. 29 December 2020
China's National Health Security Administration (NHSA) has announced the annual results from the National Reimbursement Drug List (NRDL) negotiations in 2020, according to a client noted from SVB Leerink Research analyst Andrew Berens. 28 December 2020
Takeda Pharmaceutical has signed an agreement to divest a portfolio of five select non-core prescription pharmaceutical products sold in China to Chinese firm Hasten Biopharmaceutic. 21 December 2020
Otsuka Pharmaceutical has acquired rights for the development and commercialization of oral voclosporin to treat lupus nephritis (LN) in the European Union (EU) and Japan as well as the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. 18 December 2020
Privately-held US drug developer Oncoceutics says it has out-licensed the rights to the company’s lead compound, ONC201, for Greater China to China Resources Sanjiu Medical & Pharmaceutical (CR Sanjiu). 17 December 2020
China and USA-based Harbour BioMed (HBM) and the Netherlands’ Utrecht University (UU) have licensed their fully human, SARS-CoV-2 neutralizing antibody, 47D11 program, to US pharma major AbbVie for the prevention and treatment of COVID-19 and related coronaviruses. 16 December 2020
Japanese firms Ono Pharmaceutical and Chordia Therapeutics have agreed a licensing deal on CTX-177, the latter company’s MALT1 inhibitor and its related compounds. 15 December 2020
Japanese drug major Chugai Pharmaceuticals has concluded a license agreement with Swiss giant Roche for the development and commercialization in Japan for the antibody cocktail of casirivimab and imdevimab (formerly known as REGN-COV2) for COVID-19. 11 December 2020
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that a Marketing Authorization Application for emapalumab has been accepted for review in China. 10 December 2020
Following regulatory bids in Europe and Japan, aducanumab developers Biogen and Eisai have now formally submitted for approval in Japan. 10 December 2020
Takeda Pharmaceutical yesterday provided an update on its pipeline portfolio, which it says has the potential to contribute significantly to revenue growth for the company over the next decade, during its ‘Wave 1 Pipeline Opportunity’ call. 10 December 2020
Overland Pharmaceuticals has announced its official launch with a mission to bring innovative medicines to underserved patients in Asia and around the world. 9 December 2020
Japanese drug major Chugai has obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent over 12 years old patients who are anti-aquaporin-4 (AQP4) antibody positive. 9 December 2020
Beijing’s Sinovac Biotech has secured approximately $500 million in funding for further development, capacity expansion and manufacturing of its coronavirus vaccine. 8 December 2020
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
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