Ferring China chief executive Eric Breumier says the company will keep its long-term commitment in China and will continue to invest in the country, reports The Pharma Letter’s China correspondent, Wang Fangqing. 12 July 2021
Japanese drug major Chugai Pharmaceuticals has entered into an option and license agreement with Chinese biotech Alebund Pharmaceuticals (Hong Kong), regarding Chugai’s EOS789, an investigational agent under development for hyperphosphatemia. 10 July 2021
As across the world, the migraine therapeutics landscape in Japan is growing with the recent approval of calcitonin gene-related peptide (CGRP) inhibitors as preventative treatment. 8 July 2021
Sino-American biotech BeiGene said yesterday 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-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy. 8 July 2021
Japanese drug major Chugai Pharmaceutical has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for the antibody cocktail casirivimab and imdevimab (formerly known as REGN-COV2) for the treatment of COVID-19. 30 June 2021
Virtual clinical development specialist Phesi has published a new data analysis on growth in recruiting clinical trial sites in China since the beginning of 2018. 29 June 2021
Dutch biotech firm Vivoryon Therapeutics saw its share rise nearly 8% to 17.60 euros in late morning trading, after it announced a regional licensing partnership with China-based Simcere Pharmaceutical to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer’s disease (AD) in Greater China. 29 June 2021
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval for Evrysdi (risdiplam) Dry Syrup 60mg for the treatment of spinal muscular atrophy (SMA). 24 June 2021
Leading PARP inhibitor Lynparza (olaparib) has secured conditional approval in China for certain people with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). 24 June 2021
French metabolic diseases biotech company Poxel has secured approval for a first-in-class type 2 diabetes medicine, Twymeeg (imeglimin hydrochloride). 24 June 2021
Orpathys (savolitinib) has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. 23 June 2021
Iksuda Therapeutics, a privately-held UK-based developer of antibody drug conjugates (ADCs) with raised therapeutic index, has expanded its research collaboration and license agreement with Korean biotech LegoChem Biosciences. 22 June 2021
China has made its latest patent amendments effective from June 1, 2021, reforms which are likely to ensure protection against untimely and unfair generic competition. 15 June 2021
Japanese drugmaker Daiichi Sankyo says it has received conditional and time-limited approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Delytact (teserpaturev/G47∆), an oncolytic virus, for the treatment of patients with malignant glioma. 14 June 2021
Tokyo’s Chugai Pharmaceutical has announced that it has submitted for approval in Japan for faricimab, an anti VEGF/anti Ang-2 bispecific antibody. 14 June 2021
mCureX, a subsidiary of RNAi company OliX Pharmaceuticals, has signed deals with Samyang Holdings to advance development of a mRNA vaccine for COVID-19, and with GC Pharma to develop mRNA vaccines and therapeutics for respiratory infections and other diseases. 10 June 2021
Singapore-based clinical-stage biotech Hummingbird Bioscience, which just last month closed a $125 million financing round, has announced a strategic partnership with Asian genomic sequencing and bioinformatics company Novogene. 10 June 2021
Shares of Nippon Chemiphar shot up 22% to 2,771 yen today, after it disclosed a partnership with fellow Japanese drugmaker Sumitomo Dainippon Pharma. 9 June 2021
Shares of US biotech Mirati Therapeutics closed down 2.4% at $154.32, even though it announced a licensing deal for its lead drug candidate. 2 June 2021
Shares of Japanese drugmaker Kyowa Kirin (TYO: 4151) were up 8% at 3,560 yen on news of a lucrative licensing deal for its atopic dermatitis candidate with a long-time partner. 2 June 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