South Korea has recently decided to provide practical support to innovative pharmaceutical companies by revising the existing health insurance benefits system. 8 September 2021
Blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by China’s National Medical Products Administration (NMPA) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ). 7 September 2021
Shanghai, China headquartered Zai Lab has announced that the Taiwan Food and Drug Administration has approved its New Drug Application (NDA) for Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST). 6 September 2021
Chinese drug developer JW Therapeutics saw its shares rocket 28% to HK$22.80 today, as it announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA)... 6 September 2021
Japan’s largest drugmaker Takeda Pharmaceutical today revealed that the Phase III PANTHER (Pevonedistat-3001) study did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). 2 September 2021
Brukinsa (zanubrutinib) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 2 September 2021
Chinese biopharma firm Innovent Biologics and US biotech Bolt Biotherapeutics have announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates. 31 August 2021
Japanese pharma major Eisai has concluded a license agreement concerning dotinurad, a treatment for hyperuricemia and gout discovered by Fuji Yakuhin, for development and distribution in five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand. 31 August 2021
Daiichi Sankyo has concluded an agreement on commercialization collaboration in Japan with the local subsidiary of US pharma major Eli Lilly for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines. 31 August 2021
Approval has been granted for the combination of Opdivo (nivolumab) intravenous infusion and Cabometyx (cabozantinib s-malate) tablets in Japan for the treatment of unresectable or metastatic renal cell carcinoma (RCC), for a partial change in approved items of the manufacturing and marketing approval. 25 August 2021
Sino-America biotech firm BeiGene today said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). 23 August 2021
Japanese drugmaker Ono Pharmaceutical closed up 1% today, after it announced that its Ono Pharma Korea Co unit has received marketing approval for Braftovi (encorafenib) Capsule 75mg, a BRAF inhibitor, from the Ministry of Food and Drug Safety (MFDS) in South Korea. 20 August 2021
Japanese drug major Takeda Pharmaceutical’s TAK-994 has recently received Breakthrough Therapy designation (BTD) from the US Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1). 20 August 2021
Research from industry analyst GlobalData shows that domestic drug developers in China are leading the way in CAR-T cell therapy trials, with 337 company-sponsored studies underway. 19 August 2021
Shares of China-headquartered Adagene were down 3.9% at $17.10 in early trading, despite the company today announcing that it has entered into a third clinical trial collaboration and supply agreement with US pharma giant Merck & Co 19 August 2021
The China National Medical Products Administration (NMPA) has granted Qarziba (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above, said the drug’s developers, UK-based EUSA Pharma and China’s BeiGene, whose shares rose 1.8% to $286.64 on the news. 18 August 2021
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