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Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
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China’s National Joint Procurement Office Unveils Renewed Insulin Procurement Contracts
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The National Joint Procurement Office in China announced the upcoming renewal of drug procurement contracts for insulin products previously involved in the volume-based procurement (VBP) program. The renewal process is set to commence on April 23, 2024, with the procurement cycle valued at RMB 11.5 billion (USD 1.59 billion). The…
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FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
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Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication extension filing from Japan’s Eisai (TYO: 4523) for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy intended as a once-monthly maintenance treatment for early Alzheimer’s disease (AD). Currently, the intravenous therapy has conditional approval in the United…
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Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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Chinese Scientists Discover Breakthrough Biodegradable Piezoelectric Material for Medical Implants
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A team of Chinese scientists from Southeast University in Nanjing has made significant strides in the development of advanced materials for medical implants. Their research focuses on creating a transient implantable piezoelectric material that addresses the issues of biodegradability and brittleness commonly found in current options. These piezoelectric materials are…
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China’s CNIPA Upholds Patent for Nobel-Winning CRISPR/Cas9 Gene Editing Technology
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The China National Intellectual Property Administration (CNIPA) has upheld a key patent surrounding the CRISPR/Cas9 gene editing technology, rejecting an invalidation challenge. The decision was announced by ERS Genomics Ltd, an Ireland-based company founded by Dr. Emmanuelle Charpentier, the Nobel prize-winning co-inventor of the technology, to manage and license access…
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Shanghai Unveils Massive Investment Projects and Funds to Boost High-Tech Industries
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Shanghai has unleashed a flurry of policy-backed project signings and initiatives, marking a significant boost for key industries in the region. In the first quarter of 2024, a total of 420 major investment projects, each valued at over RMB 100 million (USD 13.8 million), were executed, culminating in a total…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…