UK pharma major AstraZeneca says its Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D). 5 September 2022
Clover Biopharmaceuticals, a Chinese vaccines and biologics company, has announced positive Phase II/III trial data demonstrating that its lead COVID-19 vaccine candidate, SCB-2019, elicited a robust immune response to the Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today. 31 August 2022
Taiho Pharmaceutical, a subsidiary of Japanese drugmaker Otsuka Holdings, says it has launched the oral heat shock protein (HSP) 90 inhibitor Jeselhy (pimitespib) tablets 40mg in Japan. 31 August 2022
Sino-American RNAi therapeutics company Sirnaomics has announced that the cohort receiving the 180μg dose in its Phase II trial of STP705 (cotsiranib) for cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment. 30 August 2022
AstraZeneca's (LSE: AZN) Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. 30 August 2022
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
In just three months, Henlius’ heavily invested PD1 blockbuster Hansizhuang (serplulimab) rewarded the company with nearly 80 million renminbi ($11.6 million) since its launch in March 2022 in China to treat microsatellite instability-high (MSI-H). 27 August 2022
Finch Therapeutics yesterday announced that it will regain full development and commercial rights to FIN-524 (previously known as TAK-524) and FIN-525 from Japanese pharma major Takeda Pharmaceutical. 26 August 2022
As China seeks to increase its population size, another priority is to combat diseases prevalent in its population, such as human epidermal growth factor receptor 2-negative/hormone receptor-positive breast cancer (HER2-/HR+ BC). 26 August 2022
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Japanese pharma major Takeda announced the company’s dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; formerly known as TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. 23 August 2022
Roche majority-owned Japanese drugmaker Chugai Pharmaceutical has entered into a license agreement for Noile-Immune Biotech’s proprietary PRIME (proliferation-inducing and migration-enhancing) CAR-T technology. 22 August 2022
Japanese drugmaker Kyowa Kirin said on Friday that the European Commission (EC) has approved Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults. 20 August 2022
Cell and gene therapies could become more affordable in India thanks to a raft of new biotech startups in the country focused on this therapy area. 18 August 2022
Shanghai, China-based Jemincare today announced entering into an exclusive worldwide license agreement with Swiss pharma giant Roche and its US subsidiary Genentech, for the development and commercialization of its androgen receptor degrader, JMKX002992. 18 August 2022
Shares of China-based immuno-oncology-focussed biotech I-Mab plunged more than 13% to $6.90 yesterday, after the company revealed in a filing with the Securities and Exchange Commissions that AbbVie has discontinued a Phase I trial of I-Mab's anti-CD47 monoclonal antibody lemzoparlimab, which the US pharma major in-licensed for an upfront $180 million 2020. 18 August 2022
Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
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.