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Biotechnology
The Japanese business of Swiss biotech Idorsia has launched Pivlaz (clazosentan), a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm. 20 April 2022
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has signed a collaboration agreement with France’s Domain Therapeutics and Université de Montréal (UdM) to discover novel small molecules targeting G-protein coupled receptors (GPCRs) in the metabolic disease area. 19 April 2022
Biotechnology
Japan’s largest drugmaker Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Nuvaxovid intramuscular injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. 19 April 2022
Biotechnology
Shionogi and fellow Japan-based NEC Corporation have executed a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. 19 April 2022
Pharmaceutical
Japanese companies Teijin Limited and JCR Pharmaceuticals have decided to terminate their co-development and Japan licensing agreement aimed at developing JTR-161, an allogeneic regenerative medical product containing dental pulp stem cells (DPCs) for the intended purpose of helping patients recover from acute cerebral infarctions (strokes). 19 April 2022
Biotechnology
Sino-American biotech firm BeiGene has announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. 19 April 2022
Biotechnology
China-based biotech BeiGene has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 April 2022
Biotechnology
The European Commission (EC) has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. 14 April 2022
Biotechnology
Japan’s largest drugmaker Takeda today announced that the Phase III SHP643-301 study evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients aged two to 13 April 2022
Pharmaceutical
The make-up of Australia’s Health Technology Assessment (HTA) Review Reference Committee has been announced. 11 April 2022
Biotechnology
US biotech Seagen announced that a jury in the US District Court for the Eastern District of Texas found that Japanese pharma major Daiichi Sankyo infringed Seagen’s US Patent No 10,808,039 by selling its cancer drug Enhertu (trastuzumab deruxtecan; DS-8201) in the USA. 11 April 2022
Biotechnology
China and USA-based Harbour BioMed saw its shares rocket as much as 65% on Thursday, after it announced a global out-license agreement with AstraZeneca for CLDN18.2xCD3 bispecific antibody (HBM7022), a novel bispecific antibody generated from Harbour's HCAb based immune cell engagers (HBICE) platform. 8 April 2022
Pharmaceutical
A Feature on the Japanese pharma market from Patrick Branch, a Partner in LEK's Tokyo office and a member of the firm’s Life Sciences practice. 8 April 2022
Biotechnology
Japan’s SanBio Group has announced that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase II STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). 8 April 2022
Biotechnology
The third of a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 7 April 2022
Pharmaceutical
China’s Kintor Pharmaceutical has announced the top-line results of a Phase III trial of its COVID-19 antiviral proxalutamide. 6 April 2022
Biotechnology
Ondexxya (recommend andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 29 March 2022
Biotechnology
Japan’s largest drugmaker Takeda says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for Takhzyro (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan. 29 March 2022
Biotechnology
In what was a busy day for the Japanese regulator, the Ministry of Health, Labor and Welfare (MHLW) yesterday announced a number of approvals, both new drugs and new indications. 29 March 2022
Biotechnology
China’s Innovent Biologics (HKEX: 01801) saw its shares rise 6.9% to HK$28.55 in late trading today, after it announced an expansion of its strategic collaboration with US pharma major Eli Lilly. 29 March 2022
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
Shanghai-based Zai Lab and New York’s Pfizer are to work together on the commercialization of Xacduro (sulbactam-durlobactam) in China. 22 November 2024
Biotechnology
Hong Kong-based Sino Biopharm has signed an equity investment and strategic collaboration agreement with LaNova Medicines, advancing its oncology focus. 22 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
Pharmaceutical
Big pharmas are not deterred by China’s increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. 18 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
Chinese biotech Keymed Biosciences has entered an exclusive licensing agreement with Platina Medicines for its bispecific antibody candidate, CM336. 18 November 2024
Pharmaceutical
In yet another sign of the mounting interest in radiopharmaceuticals, Tongrui Biopharma, a Chinese innovator in this area, has announced the completion of a $100 million series A+ financing round. 18 November 2024
Biotechnology
Shanghai-based biopharma Zai Lab has announced the pricing of its underwritten public offering at $25.50 per share, aiming to raise around $200 million. 15 November 2024
Biosimilars
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Biotechnology
Merck & Co has entered into an exclusive global license to develop, manufacture and commercialize LM-299 from China-based clinical-stage biotech LaNova Medicines, bringing the US pharma giant into the newly attractive PD-1/VEGF bispecific antibody space. 15 November 2024
Biotechnology
Japanese drugmaker Nippon Shinyaku and USA-based Atsena Therapeutics have entered into an exclusive license agreement for the commercialization of ATSN-101 in the USA and Japan for advancing Atsena’s first- in-class, investigational gene therapy ATSN-101 for Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). 13 November 2024
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