LIVZON Biologics Secures $148 Million Investment to Accelerate Antibody Drug Development
VCBeat (WeChat ID: vcbeat) has learned that on June 23, Livzon Pharmaceutical Group Inc. (“Livzon Group”) issued an announcement stating that, to promote the development and expansion of Livzon Group’s biopharmaceutical business in both domestic and international markets, and to accelerate the progress of its controlled subsidiary, Zhuhai CityLivmonalimabTo support the antibody drug research and development progress of Livzon Biologics Co., Ltd. (abbreviated as “Livzon Monoclonal Antibody”) and meet its growing capital needs during business development, Livzon International Limited, a wholly-owned overseas subsidiary of Livzon Group, and YF Pharmab Limited, an affiliate under Yunfeng Capital, intend to jointly increase the capital of Livzon Biologics Limited in cash.
Editor's Note:Livzon Group holds 100% equity interest in Livzon International Limited through its wholly-owned subsidiary, Livzon (Hong Kong) Co., Ltd. Livzon Biologics Limited is a company incorporated in the Cayman Islands, of which Livzon International Limited currently holds a 51% equity interest. Furthermore, Livzon Biologics Limited holds 100% equity interest in Livzon Monoclonal Antibody through its wholly-owned subsidiary, Livzon Biotech Hong Kong Co., Ltd.
On June 22, 2018, Livzon International Limited and its related controlling parties (including Livzon Group and Livzon (Hong Kong) Limited), Livzon Biologics Limited and its wholly-owned subsidiaries (including Livzon Biotech Hong Kong Co., Ltd. and Livzon Monoclonal Antibody), together with YF Pharmab Limited, jointly entered into the Share Subscription Agreement (hereinafter referred to as the “Agreement”).
According to the provisions of the Agreement,YF Pharmab Limited agrees to contribute USD 50 million to subscribe for Livzon Biologics Limited’s newly issued 12.5 million shares of Series A preferred stock; Livzon International Limited agreed to contribute US$98,299,320 to subscribe for 24.57 million newly issued ordinary shares of Livzon Biologics Limited, totalingCapital Contribution of $148 Million. Meanwhile, the shareholding structure of Livzon Mabpharm has changed, with Livzon Group holding 55.13%, Joincare Pharmaceutical Group holding 35.75%, and Yunfeng Capital holding 9.12% in preferred shares.
As of March 31, 2018, Livzon Biologics Limited, the investment target, reported total assets of RMB 403 million, total liabilities of RMB 764 million, and net assets of negative RMB 361 million. For the period from January to March 2018, its operating revenue was RMB 0.00, and its net profit was negative RMB 33.03 million.
Introduction to Livzon Biologics Limited
According to available data, in November last year, Livzon Mabpharm received the “Drug Clinical Trial Approval” (Approval No.: 2017L04883) approved and issued by the former China Food and Drug Administration.
“Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection” underwent two years of research and development, and its initial application for clinical trials was accepted on December 26, 2016 (Acceptance Number: CXSL1600125 Yue). Patents for the drug’s molecular sequence and indications have been filed in China and under the Patent Cooperation Treaty (PCT).
The Investigational New Drug (IND) application for “Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection” was officially submitted on June 29, 2017 (U.S. time) and accepted by the U.S. FDA (Acceptance Number: IND133742), and received formal approval from the U.S. FDA on July 28, 2017 (U.S. time).
“Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection” is indicated for the immunotherapy of various advanced solid tumors. It blocks the PD-1/PD-L1 immune checkpoint signaling pathway, thereby promoting T cell-mediated anti-tumor immune responses. Preclinical in vivo metabolic studies have demonstrated that the drug exhibits essentially linear pharmacokinetics. Furthermore, preclinical pharmacological and toxicological studies have indicated that the drug possesses a favorable safety and efficacy profile.
Livzon Group, through its wholly-owned overseas subsidiary Livzon International Limited, jointly increased capital in Livzon Biologics Limited with YF Pharmab Limited, primarily for Livzon Monoclonal Antibody in the domestic and international markets.Clinical Research and Regulatory Submission, Technical Collaboration, Product In-Licensing, and Strengthening of R&D Teamsprovide sufficient funding for business development, while optimizing its capital structure to promote the integration of capital and resources, thereby accelerating the efficiency and pace of business operations.
Following the financing round, Livzon Mabwell secured approximately $148 million to meet funding requirements for overseas R&D and clinical development. Currently, the company’s primary need for overseas clinical funding stems from its U.S. clinical program for the PD-1 monoclonal antibody. The Phase I clinical trial of this PD-1 monoclonal antibody in the United States is progressing smoothly, with expectations to advance to Phase III clinical trials within the year.