Yangtze River Pharma Partners with Ractigen Therapeutics on Small Nucleic Acid Drugs; Alphamab Oncology Licenses Metabolic Candidates to Bio-Thera; Zelgen Biopharma Inks Commercialization Deal with Grand Life Sciences

Dec 18, 2023 18:40 CST Updated 18:40

Ractigen

Innovative Drug R&D Developer

Yangtze River Pharmaceutical Group

Pharmaceutical and Health Service Providers

Ractigen Therapeutics and Yangtze River Pharmaceutical Group Co., Ltd. Reach Strategic Cooperation to Develop Novel Small Nucleic Acid Drugs

Recently, Ractigen announced a strategic cooperation with Shanghai Hailu, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group Co., Ltd., to jointly accelerate the research and development and commercialization of small nucleic acid drugs and develop more innovative drugs with global competitiveness.

It is reported that small nucleic acid drugs are the third generation of new drug models following small molecule drugs and large molecule drugs. Unlike small molecules and protein drugs, small nucleic acid drugs target genes, addressing disease issues upstream, with a wide range of indications and targets, capable of targeting what small and large molecules cannot. Compared to small molecule and large molecule drugs, small nucleic acid drugs have the advantages of high specificity, high stability, long-lasting efficacy, short research and development cycles, and high success rates in development.

This collaboration will focus on the research and development of innovative small nucleic acid drugs, including the development of RNA drugs for designated targets, dual-target RNA drugs, licensing of small nucleic acid drug delivery technologies, and licensing of ongoing product pipelines, among other aspects. Both parties will fully leverage Ractigen Therapeutics' advanced small nucleic acid drug development technology and world-leading intra- and extra-hepatic delivery technology, combined with Yangtze River Pharmaceutical Group Co., Ltd.'s clinical development and commercialization strengths in the pharmaceutical field, to jointly advance the commercialization of small nucleic acid drugs and the transformation of delivery technology achievements, providing more innovative treatment options for patients worldwide.

Suzhou Alphamab and Amoytop Biotech Reach Licensing Collaboration for Biologics

On December 6, Suzhou Alphamab and Amoytop Biotech jointly announced that they had signed a cooperation agreement for the rights and licensing of KN056 or KN069 (licensed products), which were independently developed by Suzhou Alphamab.

According to the terms of the agreement, the licensed products are authorized for use in mainland China, with the licensed therapeutic area being the prevention and/or treatment of non-alcoholic steatohepatitis (NASH, or fatty liver-related metabolic diseases). Amoytop Biotech will have exclusive responsibility for the clinical development and commercial sales of the licensed products within the authorized scope. They will also pay Suzhou Alphamab a total of up to RMB 490 million in milestone payments (including upfront and milestone payments) as well as sales royalties based on a certain percentage of net sales. Suzhou Alphamab retains all rights to KN056 and KN069 outside the licensed scope.

It is reported that both KN056 and KN069 are biologic innovative drugs independently developed by Suzhou Alphamab for regulating human metabolism. KN056 has a significantly prolonged half-life in the body compared to existing weekly GLP-1 agonists, which is expected to further reduce dosing frequency and improve patient compliance and convenience. KN056 has entered Phase 1 clinical trials in healthy subjects in both China and New Zealand, targeting type 2 diabetes as its indication, and so far, it has demonstrated good safety and tolerability. KN069 exhibited significant metabolic regulatory functions in preclinical studies.

Zelgen Pharma Collaborates with Grand Life Sciences Group

On December 7, Zelgen Biopharmaceuticals announced an exclusive commercialization cooperation agreement with Liaoning Yuanda, a wholly-owned subsidiary of Yuanda Life Science Group, for recombinant human thrombin. Zelgen Biopharmaceuticals authorized Liaoning Yuanda as the exclusive marketing service provider for recombinant human thrombin in Greater China.

According to the agreement, YDLN will pay Zelgen Biopharmaceuticals an upfront payment and commercial milestone payments totaling up to 400 million RMB, including an upfront payment of 260 million RMB and a commercial milestone payment of 140 million RMB upon reaching 12 months of the first commercial sale. Additionally, after achieving the sales milestones specified in the agreement, YDLN will pay Zelgen Biopharmaceuticals sales milestone payments of up to 915 million RMB. Meanwhile, Zelgen Biopharmaceuticals will pay YDLN market promotion service fees as stipulated in the agreement.

Recombinant Human Thrombin is a highly specific human serine protease developed based on Zelgen Pharmaceuticals' complex recombinant protein and antibody new drug research, development, and industrialization platform. It is currently the only recombinant human thrombin product in China that has been produced using recombinant gene technology and successfully completed Phase III clinical trials. Recombinant Human Thrombin has high technical barriers and unique advantages. Globally, the only similar product is Recothrom, which has been marketed and sold overseas for many years.

In April 2022, Zelgen Biopharmaceuticals submitted a marketing authorization application for recombinant human thrombin to the National Medical Products Administration (NMPA); in May 2022, the biologics marketing authorization application for the drug was accepted; in July 2022, Zelgen Biopharmaceuticals received a notice from the Center for Drug Evaluation (CDE) regarding on-site inspection for registration and clinical trial data verification. Currently, the marketing application for recombinant human thrombin has completed on-site clinical inspection, production, and the two-in-one inspection for registration, with the review process proceeding normally.

Editor: yc