Recent Articles in Trials & Approvals

Longbio Pharma (Suzhou) released results from a Phase II trial of its lead drug, LP-003, showing 100mg of LP-003 offered the same efficacy as 300mg of omalizumab, the current standard of care, in patients with allergic rhinitis. Both therapies are anti-IgE antibodies, but LP-003, which binds a new target, has shown better bioactivity than omalizumab in subgroup analysis. LP-003 is a novel monoclonal anti-IgE antibody that was generated and engineered by Dr. Nai-chau Sun, who co-founded Longbio and also invented omalizumab. Longbio believes LP-003 has potential to be best-in-class. More details....

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Legend Biotech reported Europe’s CHMP recommended approval of its lead CAR-T drug, Carvykti®, for a new indication: second-line therapy for adult patients with relapsed and refractory multiple myeloma. Carvykti® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy. It is currently indicated to treat adult M/M patients as a fifth-line therapy. The filing was conducted by a subsidiary of Janssen, Legend’s partner on the drug. Legend was spun out of Nanjing’s GenScript, though it now lists Somerset, NJ as its global headquarters while continuing to operate in Nanjing as well. More details...

Stock Symbol: (NSDQ: LEGN)

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Shanghai Immunofoco was approved to begin a US Phase I trial of IMC001, an EpCAM-targeting autologous CAR-T cell product to treat EpCAM-positive advanced gastrointestinal tumors. The company was already approved to start China trials of the candidate. The US trial will enroll patients with advanced gastric cancer and gastroesophageal junction adenocarcinoma. EpCAM is a biomarker for circulating tumor cells, which are highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while having only low expression in normal tissues. Immunofoco develops cell therapy products for solid tumors. More details....

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Nanjing Simcere Pharma reported data from a Phase III trial of Sanbexin® sublingual tablets for acute ischemic stroke were published in an online Journal of American Medical Association•Neurology publication. Sanbexin is an edaravone-dexborneol combination that Simcere is developing with Nanjing’s Neurodawn Pharma, a CNS company. Simcere expects the Sanbexin® sublingual tablets will become a sequential therapy with Simcere's marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection), allowing patients to complete their treatment at home. In June 2023, China’s NMPA accepted Simcere’s NDA filing for the combination therapy. More details....

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Suzhou Innovent (HK: 01801) reported that IBI31, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, met its endpoint in China Phase III trial in patients with Thyroid Eye Disease (TED). TED is an autoimmune disease that causes bulging eyes. A rare disease, the condition usually occurs in patients with Graves' disease (GD) and is the most common orbit-related (problems with the muscles and structures of the eye) disease in adults. TED occurs in approximately 25 to 50% of GD patients. Innovent, which developed the candidate for TED, plans to file an NDA for IBI311 in China.  More details....

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