Deals and Financings
Shanghai’s LaNova Medicines has sold global rights for a pre-clinical antibody drug conjugate candidate to AstraZeneca (AZN) for $600 million (including $55 million upfront) plus royalties on sales (see story). LaNova said LM-305 targets G protein-coupled receptor, class C, group 5, member D (GPRC5D). The candidate consists of an anti-GPRC5D monoclonal antibody, a protease-degradable linker and a cytotoxic payload, monomethyl auristatin E (MMAE). LM-305, which is aimed at multiple myeloma, has IND approvals in the US and China. Founded in 2019, LaNova has four clinical-stage oncology candidates and eight pre-clinical molecules in development.
Xiamen Amoytop Biotech will collaborate with South San Francisco’s Aligos Therapeutics (ALGS) using Aligos’ platform to discover and develop oligonucleotides that treat liver diseases (see story). Amoytop will have an option to acquire Greater China rights to any discovered drugs. Aligos will receive an upfront payment and research funding along with rest-of-world rights. It will be eligible to receive up to $109 million in development and sales milestone payments for licensed products as well as tiered royalties on net sales. Aligos develops targeted therapies for NASH and viral diseases, while Amoytop focuses on immune-related cytokine medicines.
Suzhou Coherent Biopharma closed a Series B+ round that brought its B/B+ funding to $100 million, which will be used for clinical trials of the company’s two lead candidates. Coherent develops drugs from its three XDC platforms – the “X” standing for all forms of drug conjugates, including ADC and PDC. Coherent will use the proceeds for clinical development of its bi-targeting XDC drug pipeline, which is aimed at treating breast cancer, solid tumors and prostate cancer. The Series B+ round was led by HM Capital. Shengdi Investment, a subsidiary of Hengrui Pharma, led the $75 million Series B round, completed last year.
Drug Farm, a Shanghai-Connecticut biopharma, raised $27 million from China investors, the first tranche of a C round to support trials of its two lead projects, a hepatitis B candidate and a cardio-renal therapy. The company uses genetics and AI technologies to discover innovative immune-modulating therapies for hepatitis B, cancer and autoimmune diseases. Two years ago, the company closed a $56 million funding. The latest funding was led by YD Capital with participation from Jiashan County State-owned Assets Investment and Betta Capital.
Chengdu’s Keymed Biosciences (HK: 02162) partnered with Shanghai Rona Therapeutics to discover first-in-class siRNA therapeutics for severe kidney diseases, also known as glomerulonephritis. Rona will use its proprietary RAZOR™ platform to discover and identify siRNA lead compounds aimed at a novel glomerulonephritis target, and Keymed will contribute biologic research and translational expertise. The collaboration will build on Rona’s proprietary platform for RNAi targeting of liver and extrahepatic tissues. The two companies have signed a profit/loss agreement to develop and commercialize candidates from the collaboration, though details were not disclosed.
Trials and Approvals
Jiangsu Hengrui Medicine (SHA: 600276) reported a global Phase III trial of its PD-1 inhibitor camrelizumab and VEGFR inhibitor apatinib met its endpoint in newly diagnosed patients of liver cancer. The combination therapy offered improved overall survival compared to Bayer’s (OTCPK:BAYZF) Nexavar. Evelvar, Hengrui’s US partner for the drugs, filed for US approval of the PD-1. Although the FDA has rejected two other China PD-1 candidates over the last year, Evelar’s NDA data derives from a global Phase III trial that includes US patients, which the earlier NDAs did not. There are two potential problems, however: Nexavar, the benchmark when Hengrui started trials, has now been replaced by Roche’s (OTCQX:RHHBY) PD-L1/VEGF combination of Tecentriq/Avastin as the leading therapy, and neither camrelizumab nor apatinib are approved in the US, asking the FDA to approve both at one time.
Shanghai CARsgen Therapeutics (OTCPK:CRTHF; HK: 2171) started enrolling patients in a US Phase II trial of CT041, a CAR-T candidate, in patients with CLDN18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) (see story). CT041 is an autologous CLDN18.2 CAR T-cell candidate that, CARsgen believes, could be the first in class globally. CARsgen’s lead drug, a BCMA CAR-T-Cell therapy, is currently under NDA review in China for relapsed/refractory multiple myeloma. The company develops CAR-T therapies for hematological and solid tumor cancers in China and the US.
Beijing CANbridge Pharma (HK: 1228) reported positive data from its second-gen gene therapy for spinal muscular atrophy in preclinical tests. In a mouse model of SMA, a novel second-gen hSMN1-AAV gene therapy vector improved life span and motor function better than the benchmark vector, The therapy was delivered via intracerebroventricular (ICV) injection, consisting of an endogenous SMN1 promoter and codon-optimized human SMN1 transgene. CANbridge, which developed the novel therapy together with UMass Chan Medical School, develops rare disease and rare oncology therapies.
Boan Biotech (HK: 6955), a Shandong biologics company spun out of Luye Pharma, was approved to start China trials of BA1202, a CEACAM5 (CEA)/CD3 bispecific antibody. The candidate is aimed at CEA-positive solid tumors, including colorectal cancer, non-small cell lung cancer, pancreatic cancer and gastric cancer. BA1202 is the first CEA/CD3 bispecific antibody approved for a clinical trial in China. Boan is a biotech company that completed an IPO in Hong Kong in late 2022. The company, which focuses on novel biologics and biosimilars, had been the Luye Pharma’s biologic drug subsidiary.
Gracell Biotechnologies (GRCL), a Shanghai-San Diego CAR-T company, reported its dual-targeting BCMA/CD19 autologous FasTCAR will begin a China investigator-initiated trial for refractory systemic lupus erythematosus (SLE). The FasTCAR platform prepares a clinical dose overnight. GC012F, a next-gen CAR-T CD19/BCMA candidate, has already started trials for two multiple myeloma indications and B-cell non-Hodgkin’s lymphoma. The new SLE trial is the first time GC012F has been tested in patients with an autoimmune disease.
Disclosure: None.
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