Japanese drugmaker Chugai Pharmaceutical announced that its in-house developed Enspryng [satralizumab (genetical recombination)] has received forerunner designation for the expected indication of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE) from the Ministry of Health, Labor and Welfare (MHLW). 24 March 2023
Japan’s largest drugmaker Takeda says it will invest around 100 billion yen ($758 million) to build a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. 24 March 2023
UK immune-oncology company Macomics has entered into a worldwide drug discovery collaboration with Japan’s Ono Pharmaceutical to develop new antibody drugs against a novel macrophage target of interest in cancer. 23 March 2023
US drug developer Biohaven, which is reinventing itself after selling its migraine business to Pfizer for $11 billion last year, says it has acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders. 23 March 2023
The Singapore Health Sciences Authority (HSA) has approved its 20-valent pneumococcal conjugate vaccine (PCV20) that protects against invasive pneumococcal disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. 18 March 2023
China’s National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. 17 March 2023
Esperion Therapeutics’ shares plunged by over 60% to $1.64 on Thursday, after it stated in a company filing with Securities and Exchange Commission (SEC) that Daiichi Sankyo Europe has disputed Esperion’s right to receive milestone payments following a clinical trial. 17 March 2023
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC). 10 March 2023
The US subsidiary of Japanese drug major Astellas Pharma today announced disappointing top-line results from the Phase III MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML). 9 March 2023
Biotech companies in the Asia-Pacific (APAC) region are trailing Western rivals in terms of venture capital financing, according to a report from GlobalData. 9 March 2023
Japanese biotech Carna Biosciences has terminated a licensing deal with its Chinese partner BioNova Pharmaceuticals and regained all China rights of the asset AS1763, a BTK inhibitor treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell non-Hodgkin lymphoma (B-cell NHL). 8 March 2023
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use. 6 March 2023
Japanese drugmakers Kyorin Pharmaceutical and Sumitomo Pharma have entered into a license agreement for the development, manufacturing, and commercialization of vibegron, a therapeutic agent for overactive bladder (OAB), in Taiwan, Hong Kong, Singapore, Indonesia, and Vietnam. 6 March 2023
Japan’s Teijin Parma has entered into an exclusive global license agreement with Swiss pharma giant Novartis to research, develop, manufacture and commercialize an investigational pre-clinical candidate for proteinuric kidney diseases. 6 March 2023
South Korea’s Celltrion Healthcare saw its shares gain more than 7% to 57,700 Korean won on Friday, after it presented new data for its novel subcutaneous infliximab treatment, CT-P13 SC, also known as Remsima, at the European Crohn’s and Colitis Organization congress last week. 6 March 2023
Taiwan generics drugmaker Lotus Pharmaceuticals has received approval in Vietnam for its cancer drug vinorelbine soft gel in two varieties - 20mg and 80mg- to compete with the branded version Navelbine, originated by French drugmaker Pierre Fabre. 3 March 2023
USA-based Ambrx Biopharma and partner NovoCodex Biopharmaceuticals have announced an update on ACE-Breast-02, a Phase III breast cancer trial. 2 March 2023
Florida, USA-based Avenue Therapeutics, which was founded by Fortress Biotech, today announced that it has entered into an exclusive license agreement with AnnJi Pharmaceutical, a Taiwanese clinical-stage drug company. 2 March 2023
Shanghai Junshi Biosciences had more positive news, this time on its monoclonal antibody (MAb) candidate ongericimab, adding to the successful trials results for its toripalimab in breast cancer last week. 1 March 2023
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Nxera Pharma has entered a new commercial partnership agreement with fellow Japanese drugmaker Shionogi regarding the distribution and sales for Quviviq (daridorexant 25 and 50mg) in Japan. 1 October 2024
Sino-American biotech Regor Pharmaceuticals has entered into a definitive purchase agreement whereby Swiss pharma major Roche (ROG: SIX) subsidiary Genentech will acquire a portfolio of next-generation CDK inhibitors from Regor for the treatment of breast cancer. 30 September 2024
China-based Asieris Pharmaceuticals announced that the international multicenter Phase III clinical study data of its non-surgical treatment for cervical high-grade squamous intraepithelial lesion (HSIL) product Cevira (APL-1702) will be published at the 27th Chinese Society of Clinical Oncology. 30 September 2024
The National Medical Products Administration (NMPA), China's top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand. 30 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment, particularly within China's burgeoning oncology sector. 27 September 2024
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.