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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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Nanjing Triastek closed a $20 million Pre-C financing round to support development of its 3D printing process for complex drug delivery and programmed release medications. The company’s proprietary technology, the Melt Extrusion Deposition (MED®) 3D printing process, combined with digital formulation development techniques, have been put to use to create timed release drugs. Triastek is also developing new technology including Semi-Solid Extrusion, Micro-Injection Molding, and Micro-Droplet Jetting to deliver and develop oral peptides, gastric retention and high potency products. The round was led by Guoxin Investment. 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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