Deals and Financings

Pfizer (NYSE: PFE) announced a major partnership with Shanghai’s Sinopharm to market up to 12 innovative drugs in China over the next three years (see story). The goal, according to Sinopharm’s president Liu Yong, is to market the new therapies to China’s citizens as quickly as possible. Sinopharm, a division of the China’s state-owned Sinopharm Group, is one of China’s largest drug distributors. The news did not include any financial details of the agreement nor the drugs that Pfizer wants Sinopharm to market. Until now, Pfizer has done its own commercialization in China. 

VintaBio, a cell and gene therapy CDMO, opened its doors with a 22,500 square foot facility in Philadelphia after raising $64 million in a funding led by Shanghai Decheng Capital (see story). The custom-built manufacturing facility is open and accepting orders. VintaBio was founded by Junwei Sun and Dr. Shangzhen Zhou to address the viral vector bottleneck in cell and gene therapy development. The two founders developed the first viral vectors used for life-saving therapies, including the cell therapy that cured Emily Whitehead of a pediatric cancer, as well as the first two FDA-approved gene therapies. 

AI News

XtalPi, a Shenzhen AI drug development company, and German’s Merck reported a successful partnership that combined computational analysis with wet lab experiments (see story). The two companies used XtalPi’s morphology prediction platform, a screening approach for engineering crystal morphology, to predict the influence of polymer additives on the crystal habits of metformin HCI, a diabetes treatment. The addition of HPMC led to a transformation from a needle-like to a prismatic morphology. The successful results were obtained more efficiently and at a lower cost than traditional methods such as milling and micronization.

Trials and Approvals

Shanghai Genor Biopharma (HK: 6998) reported its NDA for a cyclin-dependent kinase 4/6 inhibitor was accepted for review by China’s NMPA (see story). Lerociclib is aimed at HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy. The candidate will be administered in combination with fluvestran. In 2020, Genor acquired Asia rights (ex-Japan) to lerociclib from G1 Therapeutics, a North Carolina company, in a $46 million agreement. Lerociclib was accepted for NMPA review while Genor is completing a Phase III trial that is now fully enrolled. 

Shanghai Junshi Biosciences (HK: 1877; SHA: 688180) said its PARP inhibitor met its primary efficacy endpoint as a maintenance therapy in a Phase III trial for ovarian, fallopian tube or peritoneal cancer (see story). The patients had previously experienced a full or partial response to platinum-based chemotherapy. Senaparib is being jointly developed by Junshi Biosciences and Impact Therapeutics. In 2020, the two companies formed a JV for China development of the candidate, with Junshi investing $43 million for a 50% stake in the JV while Impact contributed China rights to the drug. 

Bridge Biotherapeutics (KQ288330) has dosed the first patient in a global Phase IIa trial of its autotaxin (ATX) inhibitor to evaluate the efficacy, safety and tolerability of the candidate in patients with idiopathic pulmonary fibrosis (IPF) (see story). In 2019, Bridge completed a Phase I trial of BBT-877 showing it could inhibit lysophosphatidic acid (LPA) production by as much as 90%. LPA is known to bind to cell receptors and induce physiological activities that lead to fibrotic disease development, including IPF. Bridge, a company with Korean, US and China operations, discovers and develops novel therapeutics for ulcerative colitis, fibrotic disease and cancers. 

Shanghai JW Therapeutics (HK: 2126) to start a China Phase I/II trial of its CAR-T cell therapy in patients with moderate to severe systemic lupus erythematosus (SLE) (see story). Relmacabtagene autoleucel injection (relma-cel) is an autologous anti-CD19 CAR-T cell immunotherapy. JW said the candidate has already shown “remarkable efficacy” in published results from trials in SLE patients. The CAR-T therapy is already approved in China for two indications: third-line large B-cell lymphoma and second-line follicular lymphoma. JW is a cell therapy JV formed by Seattle's Juno Therapeutics and WuXi AppTec. http://www.chinabiotoday.com/articles/jw-trial-car-t-sle

Suzhou’s Sirnaomics (HK: 2257) announced plans to start a US Phase I trial of its novel RNAi Factor XI anticoagulant. Factor XI (FXI) is an enzyme produced in the liver that plays an important role in the body's blood clotting cascade (see story). Because FXI impacts the intrinsic coagulation pathway while leaving the extrinsic pathway and bleeding time intact, it is a prime target for anticoagulation needs in atrial fibrillation, pulmonary embolism, deep vein thrombosis, and deep venous thrombosis prophylaxis. It is the first siRNA-based candidate to target the major unmet need of anticoagulation disorders. 

China Grand Pharma (HK: 512) of Hong Kong was approved to start a China Phase I trial of a molecularly-targeted radiation therapy for newly diagnosed glioblastoma (GBM) that was developed by Telix Pharma (ASX: TLX) of Australia (see story). Telix’s TLX101 is a LAT-1 (L-type amino acid transporter 1) membrane transport protein that is often highly expressed in GBM. Grand Pharma is completing a China Phase I trial so that it can participate in Telix's global Phase III study. In 2020, Grand announced a $365 million deal to market Telix’s molecular cancer imaging and therapeutic radiation products in China. 

OnCusp Therapeutics, a New York City-Shenzhen biopharma, will release pre-clinical data on its lead candidate, CUSP06, a high affinity anti-CDH6 antibody drug-conjugate (ADC) with an exatecan payload (DAR8) (see story). It showed potent anti-tumor activity and was well-tolerated in multiple preclinical models. One year ago, OnCusp in-licensed global rights (ex-China) to CUSP06 from Multitude Therapeutics of Shanghai, which continues to hold the China rights. OnCusp’s business plan is to acquire rights to promising pre-clinical stage candidates from China companies and bring them through clinical proof-of-concept. 

Disclosure: none.