Sino-American biotech BeiGene yesterday reported financial results, showing that revenues for the fourth quarter and full year 2022 was $380.1 million, missing consensus estimates of $345 million by 2%, and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. 28 February 2023
The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. 28 February 2023
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer. 27 February 2023
The spread of the COVID-19 epidemic has basically ended in China, though it is not completely over, according to a senior health expert, quoted on the website of the country’s National Medical Products Administration (NMPA). 27 February 2023
UK pharma major AstraZeneca (LSE: AZN) saw its shares dip 1.2% after it announced an exclusive global license deal with KYM Biosciences. 23 February 2023
Ono Pharmaceutical’s shares closed down 2.3% at 2,784 yen today, after the Japanese drugmaker revealed it has signed a collaboration and option agreement with Boston, USA-based biotech Cue Biopharma (Nasdaq: CUE) for CUE-401. 22 February 2023
Drug regulators in China are focusing on approving homegrown antiviral therapies with the ability to tackle new COVID-19 variants, according to analysis from a data and analytics provider. 20 February 2023
Japanese firms Teijin and Axcelead have announced an agreement on a capital and business alliance to establish a joint venture company. 20 February 2023
US biotech Capricor Therapeutics has entered into a partnership with mid-sized Japanese drugmaker Nippon Shinyaku, for the exclusive commercialization and distribution in Japan of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. 16 February 2023
China and USA-based Harbour BioMed saw its shares rise more than 7% to HK$3.17, after it announced an exclusive license agreement with US firm Cullinan Oncology for the development and commercial rights on HBM7008 (CLN-418) in the USA. 14 February 2023
Contract research organization (CRO) Novotech has published a new global report on Phase I trial activity including current metrics on fast growth regions and therapeutic areas. 13 February 2023
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
Shares of Denmark’s ALK-Abello were up 7.9% at 110.90 Danish kroner by early afternoon, as the allergy immunotherapy company announced 2022 financial results and acceptance of a regulatory filing in China. 3 February 2023
A rosy future is predicted for Sino-American biotech BeiGene oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib), which recently gained US Food and Drug Administration (FDA) approval for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 31 January 2023
Exkivity (mobocertinib) is the first targeted therapy to be approved for locally-advanced or metastatic epidermal growth factor receptor (EGFR) exon 20 insertions (exon20ins)-positive non-small cell lung cancer (NSCLC) in China. 27 January 2023
The Chinese Center for Disease Control and Prevention has recorded that Omicron lineages BA.5.2 and BF.7 account for 97.5% of all local infections in the country. 25 January 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.