BioCity Biopharma, headquartered in Wuxi, China, will conduct a China Phase Ib/II trial of its BC3402, a mAb targeting the T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3), together with AstraZeneca's approved anti-PD-L1, Imfinzi (durvalumab). The trial will enroll patients with advanced hepatocellular carcinoma (HCC). BioCity believes BC3402 has the potential to be a best-in-class anti-TIM-3 mAb because it binds to multiple TIM-3 epitopes with a higher binding affinity than similar candidates. BioCity develops differentiated therapeutics for cancer and autoimmune disorders including chronic kidney diseases. More details....

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Shanghai AffaMed will begin China Phase III trials of Risuteganib (luminate®), its first-in-class injectable ophthalmic intravitreal candidate for intermediate dry age-related macular degeneration (Dry AMD). Luminate® is a first-in-class integrin regulator that regulates multiple pathways of oxidative stress response, including mitochondrial dysfunction, which contributes to intermediate Dry AMD. In 2021, AffaMed acquired greater China rights (including manufacturing) to the candidate from South Korea’s Hanmi Pharma in a $145 million agreement. AffaMed believes AM011 will be the first product in China to start Phase III development for Dry AMD. More details....

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Yantai RemeGen reported positive results from a Phase III trial of Telitacicept, the company’s autoimmune drug, as a therapy for rheumatoid arthritis. Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator and a proliferation inducing ligand (APRIL). The combination has been shown to reduce B-cell mediated autoimmune responses implicated in several autoimmune diseases. RemeGen has filed a Telitacicept NDA in China for the RA indication. In 2021, Telitacicept was approved in China to treat systemic lupus erythematosus. More details....

Stock Symbols:  (HK: 9995, SHA: 688331)

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Suzhou Gracell Biotech posted strong results from an ongoing Phase I investigator-initiated trial of the company’s dual targeting CAR-T cell therapy for multiple myeloma. GC012F produced a 100% overall response rate (ORR) and a 100% minimal residual disease (MRD) rate as a first-line therapy in 19 transplant-eligible patients. The enrollees were high-risk, newly diagnosed multiple myeloma (NDMM) patients. GC012F, Gracell’s lead drug, is a dual CD19 and B-cell maturation antigen (BCMA) candidate that also benefits from the company’s autologous FasTCAR technology, which requires only 24 hours of manufacturing time. More details....

Stock Symbol: (NSDQ: GRCL)

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Hangzhou Ascletis Pharma has enrolled the first 120 patients in the China Phase III trial of ASC40 combined with bevacizumab to treat recurrent glioblastoma. ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase, an enzyme that regulates de novo lipogenesis. ASC40 is expected to decrease energy supply and disturb the membrane phospholipid composition of tumor cells. In 2019, Ascletis acquired China rights to ASC40 from San Francisco's 3-V Biosciences for NASH. In a Phase II trial, the combination produced an overall response rate of 65% with a 20% complete response rate in patients with rGBM. More details....

Stock Symbol: (HK: 1672)

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