Sino-American biotech BeiGene saw its shares rise 3.5% to 160.51 renminbi, after it announced that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include four new indications for its PD-1 inhibitor tislelizumab. 19 January 2023
Negotiations with the China National Healthcare Security Administration (NHSA) have borne fruit for Hutchmed and its product Orpathys (savolitinib). 18 January 2023
CAR-T cell therapy specialist CARsgen Therapeutics has inked a deal with a division of Huadong Medicine for the commercialization of CT053 in China. 17 January 2023
Shares of Japanese drugmaker Eisai were lifted by more than 3% to 8,327 yen this morning, after it revealed it has filed for domestic approval of its Alzheimer’s drug Leqembi (lecanemab), which was granted accelerated approval in the USA earlier this month. 16 January 2023
Japanese companies have been late to progress COVID-19 vaccines, so news that Daiichi Sankyo had now filed for regulatory approval of its vaccine candidate sent the company’s shares up 2.2% to 4,134 yen on Friday. 16 January 2023
China’s National Medical Products Administration (NMPA) has approved Japanese pharma giant Takeda’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. 12 January 2023
Research from industry analyst GlobalData finds that western companies are likely to play an important role in providing new cardiovascular disease (CVD) management options in China. 12 January 2023
Massachusetts, USA-based biotech Selecta Biosciences’ shares were up 11% at $1.37, after it announced an exclusive licensing and development agreement with Japan’s Astellas Pharma for IdeXork (Xork). 10 January 2023
Today, US biotech Arrowhead Pharmaceuticals announced positive top-line data from a Phase II placebo-controlled study evaluating an investigational RNAi therapeutic, fazirsiran (TAK-999/ARO-AAT), for the treatment of alpha-1 antitrypsin (AATD) liver disease. 9 January 2023
The US Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. 9 January 2023
Having controversially approved the first new Alzheimer’s disease drug Aduhelm (aducanumab) in decades in 2021, dead on schedule, the US Food and Drug Administration on Friday announced its decision on a follow-on product. 7 January 2023
BioRay Pharmaceutical's claim to be China’s leading autoimmune-focused biopharmaceutical firm looks substantially more robust after the company announced a $218 million strategic financing. 6 January 2023
Chinese contract research, development and manufacturing organization WuXi Biologics has announced a license agreement with UK pharma major GSK. 6 January 2023
Armed with promising new data from the Phase III interim analysis, Japan’s largest drugmaker Takeda says it aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 (rADAMTS13) for a disorder with considerable unmet patient need. 6 January 2023
Adding to a deal with a US pharma giant last year, Cambridge, USA-based biotech Orna Therapeutics has now entered into a collaboration with Shanghai Xianbo Biotech, also known as Simnova outside of China, to discover, develop and commercialize multiple potential therapeutics in the area of oncology in China. 6 January 2023
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
AstraZeneca’s Calquence (acalabrutinib) has secured a new approval in Japan, for the treatment of adults with chronic lymphocytic leukemia (CLL), in the first-line setting. 28 December 2022
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Japanese biotech PeptiDream saw its shares gain more than 20% to 1,965 yen today, after it announced a new research collaboration and license agreement with US pharma major Eli Lilly focused on the discovery and development of novel peptide drug conjugates (PDCs). 27 December 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