Recent Articles in Trials & Approvals

Shanghai Everest Medicines reported its in-licensed kidney drug, Nefecon, met its Phase III endpoints in patients with primary IgA nephropathy (IgAN). In 2019, Everest acquired China rights to Nefecon from Sweden’s Calliditas Therapeutics in an agreement worth up to $121 million. Calliditas conducted the global Phase III trial, which enrolled 364 patients randomized 1:1 for Nefecon and placebo. Everest said the trial showed Nefecon is a disease modifying first-in-disease treatment for IgAN patients. The trial included a China arm that is expected to release final data in Q3 of 2023. More details....

Stock Symbol: (HK:1952)

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Guangzhou's Bio-Thera Solutions has started a China Phase I trial of BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4. The trial will enroll patients with advanced solid tumors to study the safety and tolerability of BAT8007 while determining the recommended Phase II dose (RP2D) of the candidate. The trial will also evaluate the pharmacokinetics and preliminary efficacy in patients. Bio-Thera said Nectin-4 is overexpressed in urothelial carcinoma, breast cancer, non-small cell lung cancer, pancreatic cancer, esophageal cancer and head and neck cancer. More details....

Stock Symbol: (SHA: 688177)

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Yantai-based Luye Pharma has completed enrollment in a China Phase III clinical trial of BA9101, a VEGFR inhibitor that is a biosimilar to Regeneron’s Eylea. Eylea is approved in the US to treat several ophthalmic indications, including Neovascular (Wet) Age-Related Macular Degeneration (wAMD). Luye’s subsidiary, Boan Biotech, is running the trial together with its partner, Shanghai’s Ocumension, which acquired China commercialization rights to the drug. In a Phase I trial, BA9101 proved to be safe and well-tolerated. Luye paid $205 million in 2019 to acquire Boan and its portfolio of eight biosimilar candidates. More details....

Stock Symbol: (HK: 2186) (HK: 6955) (HK: 1477)

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AusperBio, a Hangzhou-Boston biopharma, has started a Phase I trial in New Zealand of its novel therapy for chronic hepatitis B. AHB-137 is a pan-genotypic antisense oligonucleotide (ASO) designed to target all HBV RNA. The company believes AHB-137 has the potential to be a best-in-class therapy. The first cohort of the trial, which enrolled adult healthy volunteers and chronic hepatitis B patients, did not report any major safety issues. AusperBio is dedicated to finding best-in-class therapeutics for HBV infections and to become a world leader in antiviral therapeutics. More details....

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San Diego’s Ambrx Biopharma reported that its anti-HER2 ADC showed better progression free survival in an interim review of China Phase III trial data than the control. The trial was conducted by NovoCodex Biopharma, a Shaoxing subsidiary of Zhejiang Pharma, which in-licensed rights to the drug in 2013. NovoCodex is testing ARX788 for breast cancer, gastric/GEJ cancer and other solid tumors. Ambrx continues to hold ex-China rights to the drug, but in a recent realignment of its portfolio, Ambrx did not showcase ARX788, assigning the candidate to “Partnered Products” rather than “Prioritized.” More details....

Stock Symbol: (NYSE: AMAM)

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