Deals and Financings
Suzhou MediLink Therapeutics out-licensed global rights (ex-China) for its antibody-drug conjugate candidate against Human Epidermal Growth Factor Receptor 3 (HER3) to BioNTech (BNTX) in a $1.1 billion agreement (see story). BioNTech will pay $70 million upfront to MediLink and be responsible for more than $1 billion in milestone payments. MediLink’s HER3 ADC candidate has shown efficacy and safety in preclinical tumor models while early data supports its conceptual validation. Medilink is the fourth China biopharma to form a collaboration with BioNTech this year (see story).
BioMap, a three-year old Beijing AI drug discovery company, formed a strategic collaboration with France’s Sanofi (SNY) to co-develop new protein therapies in a deal with potential value of more than $1 billion (see story). Unlike previous drug AI companies that are based on labeled data, BioMap’s AI models enable one large model, trained on ubiquitous unlabeled data, to build multiple downstream task models. The company believes its approach offers superior prediction from limited data across a range of therapeutic areas. BioMap was founded by Robin Li and Wei Liu, who previously founded Baidu, the Beijing-based internet search and AI company.
Chongqing Zhifei Biological partnered China sales of a GSK shingles vaccine, Shingrix, for three years, starting January 1, 2024 (see story). Zhifei agreed to purchase $3 billion of the vaccine over the three-year period. To meet the goal, Zhifei will have to double the current rate of sales. Further financial details were not disclosed. The partnership could be extended if both parties agree. Zhifei also has the right of first refusal to be GSK’s partner for an RSV vaccine for older adults in China, once it is approved. Zhifei is China’s largest vaccine company by revenue.
Suzhou Gritgen Therapeutics has completed validation of its commercial gene therapy GMP facility and officially opened the plant, which is located in Suzhou Industrial Park. Initially, the company will use the facility to produce Phase III clinical and commercial supplies for its lead candidate, a gene therapy for hemophilia A. Gritgen develops adeno associated virus (AAV) gene therapies, with its next-gen AAV capsid platform and efficient promotors and enhancers. The GMP facility is built to comply with global cGMP standards, including the NMPA, the FDA and the EMA.
Trials and Approvals
Suzhou Ascentage Pharma (HK: 6855) was approved to start a pivotal global Phase III study of its Bcl-2 inhibitor APG-2575 (lisaftoclax) as a first-line therapy for lymphocytic leukemia. The candidate will be administered in combination with AstraZeneca’s (AZN) acalabrutinib, a BTK inhibitor, and compared to immunochemotherapy for efficacy and safety. Patients will have either chronic lymphocytic leukemia or small lymphocytic leukemia. In August, Ascentage was approved to conduct a US Phase III trial of the Bcl-2 inhibitor in patients with CLL/SLL who have received prior therapies.
Jiangsu Atom Bioscience has dosed the first patient in a Phase IIb/III trial of its lead drug, ABP-671, a novel orally administered URAT1 inhibitor aimed at treating chronic gout. By reducing the reabsorption of uric acid in the kidneys, ABP-671 increases the excretion of uric acid. The multicenter, randomized, double-blind trial will enroll 580 patients globally, including the US. Part I will evaluate the safety and efficacy of ABP-671 at different doses with results available by the end of 2024. Part II will be a confirmatory study.
Guangzhou Akeso (OTCPK:AKESF, HK: 9926) announced that positive results from a Phase Ib/II clinical trial of cadonilimab, a PD-1/CTLA-4 bispecific antibody, were published in The Lancet Oncology. Akeso said the trial was the first PD-1/CTLA-4 dual immune checkpoint inhibitor to be trialed for solid tumors. Cadonilimab binds different cells that express PD-1 or CTLA-4, reducing the activation of immunosuppressive pathways while increasing the T-cell-mediated immune response. Cadonilimab is the first-in-class PD-1/CTLA-4 bispecific antibody developed in China.
Suzhou Kintor Pharma (OTCPK:KNTPF, HK: 9939) announced conditional China approval for a Phase II trial of its small molecule Hedgehog/SMO inhibitor to treat idiopathic pulmonary fibrosis (IPF). Currently, there are no effective therapies to stop or cure the fibrosis process of IPF, though the Hedgehog signaling pathway become a target for addressing the disease. GT1708F is a highly active and specific inhibitor of SMO protein, which lowers activity of the Hedgehog pathway and expression of its downstream proteins, thereby treating IPF. Previously, GT1708F showed a good safety trial in a China Phase I trial for patients with hematologic malignancies.
Shanghai GenFleet Therapeutics has started a Phase Ib/II trial of GFH009, a highly selective CDK9 inhibitor, in patients with relapsed/refractory peripheral T-cell lymphomas (OTCPK:PCTL). The company previously completed Phase I dose escalation trials of GFH009 as a monotherapy for hematological malignancies in China and the US. The trials showed early signs of favorable safety/tolerability and promising clinical efficacy, with complete or partial responses observed in acute myeloid leukemia and lymphoma patients. Four PTCL patients had a clinical response.
Shanghai I-Mab (IMAB) reported positive early results from a US/Korea Phase I trial of a novel PD-L1 x 4-1BB bispecific antibody as a second-line therapy for solid tumors that were resistant to PD-(L)1 therapies. The bispecific, developed by ABL Bio of South Korea, is a combination of I-Mab’s TJ-L14B and ABL’s ABL503. Its PD-L1 arm is a tumor-dependent T-cell activator, while the 4-1BB arm activates T cells after binding the PD-(L)1 target. At a low dose, TJ-L14B/ABL produced one complete response and three partial response in 14 patients.
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