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
After decades without a breakthrough, scientists targeting the respiratory syncytial virus (RSV) have notched up three successes in a period of around a year. 2 January 2024
China’s National Medical Products Administration (NMPA) has approved Japanese pharma major Takeda’s antiviral drug Livtencity (maribavir). 29 December 2023
South Korean biotech LegoChem Biosciences has entered into a license agreement with Janssen Biotech, to develop and commercialize LCB84. 29 December 2023
Chinese biopharma Innovent Biologics and Xuanzhu Biopharma have entered into a clinical trial collaboration and supply accord for the combination therapies of Tyvyt (sintilimab) injection with KM-501. 28 December 2023
Japan’s innovative pharma market has been on an upwards trajectory these last 12 months – despite what you may have seen in IQVIA thought leadership reports, industry advocacy body pronouncements or USD-reported results. 27 December 2023
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Bimzelx (bimekizumab) for the treatment of adults with psoriatic arthritis (PsA), non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not sufficiently responding to existing treatments, said Belgian drugmaker UCB. 27 December 2023
In a bid to further its cell therapy ambitions, UK pharma major AstraZeneca has entered into a definitive agreement to acquire China’s clinical-stage biotech Gracell Biotechnologies 26 December 2023
Suzhou, China-based cancer company CStone Pharmaceuticals has inked a deal with French drugmaker Servier to sell certain rights to Tibsovo (ivosidenib). 21 December 2023
Japanese drugmaker Shionogi has launched of siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial in Japan. 21 December 2023
UK pharma major GSK and China’s Hansoh Pharma have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilizing a clinically validated topoisomerase inhibitor (TOPOi) payload. 20 December 2023
As geopolitical tension intensifies between China and the US-led West, more Chinese biotechs are actively seeking growth opportunities in the vast emerging markets, or the markets outside the USA and European Union, especially the geographically nascent ASEAN region and the wealthy Middle East region. 18 December 2023
The US Food and Drug Administration (FDA) on Friday approved Padcev (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally-advanced or metastatic urothelial cancer (la/mUC). 18 December 2023
Hot on the heels of approval from the European regulator, the UK subsidiary of Japan’s Astellas Pharma today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Veoza (fezolinetant). 18 December 2023
Antibody specialist Nona Biosciences, a wholly-owned subsidiary of Hong Kong-based HBM Holdings, has entered into an exclusive license agreement with Pfizer. 15 December 2023
The US subsidiary of South Korea-based Celltrion Healthcare has announced that Ventegra, a major US Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model, will place an FDA-approved biosimilar to Roche’s Avastin (bevacizumab), Vegzelma (bevacizumab-adcd), on its commercial formulary as a preferred brand. 14 December 2023
South Korea medicines regulator has issued guidelines to monitor the side effects of the two approved CAR-T therapies – Novartis’ Kymriah (tisagenlecleucel) and Johnson & Johnson subsidiary Janssen’ Carvykti (ciltacabtagene autoleucel). 13 December 2023
The European Commission (EC) has authorized Japanese drugmaker Astellas Pharma’s Veoza (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 11 December 2023
Singapore-based clinical-stage biotech Hummingbird Bioscience today announced the appointment of Angèle Maki, as chief business officer (CBO), with immediate effect. 11 December 2023
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.