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Genscript Biotech Corporation — Regulatory Filings 2021
Oct 22, 2021
49993_rns_2021-10-22_6a7cb5ce-267b-48e0-9a34-2d1a81c0006f.pdf
Regulatory Filings
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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
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**Genscript Biotech Corporation 金斯瑞生物科技股份有限公司 ***
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 1548)
VOLUNTARY ANNOUNCEMENT SERVICE AGREEMENT WITH ABOGENBIO AND WALVAX
The board (the “ Board ”) of directors (the “ Directors ”) of the GenScript Biotech Corporation (the “ Company ”) is pleased to announce that on 22 October 2021, Jiangsu GenScript ProBio Biotech Co., Ltd.* ( 江蘇金斯瑞蓬勃生物科技有限公司 ) (“ GenScript ProBio ”), a non-wholly-owned subsidiary of the Company, entered into a master service agreement (the “ Service Agreement ”) with Suzhou Abogen Biosciences Co., Ltd.* ( 蘇州艾博生物科技有限公司 ) (“ Abogenbio ”) and Yuxi Walvax Biotechnology Co., Ltd.* ( 玉溪沃森生物技術有限公司 ) (“ Walvax ”, together with GenScript ProBio and Abogenbio, the “ Parties ”) in relation to the cooperation on the biologic license application (the “ BLA ”) of mRNA vaccines and its commercial production (the “ Project ”). Walvax shall be the applicant for the Project and GenScript ProBio shall be the exclusive services supplier for the commercial production of plasmid for the Project.
In June 2020, the COVID-19 mRNA vaccine jointly developed by Abogenbio, Walvax and a medical institution based in the People’s Republic of China, has obtained approval from the National Medical Products Administration (the “ NMPA ”) to initiate the clinical trial, which is the first batch of COVID-19 mRNA vaccine projects approved by the state. Leveraging GenScipt ProBio’s Good Manufacturing Practices (GMP) plasmid production platform and multiple clinical plasmid production experience, GenScript ProBio has facilitated the Project to enter the clinical trial phase. As of the date of this announcement, Phase III clinical trials of the Project have been approved by the drug administration authorities of Mexico, Indonesia and Nepal. The modular plant of Walvax has been in operation since September 2021 for the commercial production of the COVID-19 mRNA vaccine.
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The Group believes that, upon the entering into the Service Agreement, the Parties will cooperate to push forward the commercialization of the COVID-19 mRNA vaccine by leveraging the advantages of the Parties so as to contribute to the prevention and control of the COVID-19 pandemic.
INFORMATION ON GENSCRIPT PROBIO
GenScript ProBio is the biologics contract development and manufacturing organization (“ CDMO ”) segment of the Group, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.
GenScript ProBio’s innovative solutions for antibody drug development include antibody drug discovery (hybridoma, antibody library, fully human transgenic mice, bispecific antibodies technologies, single b cell screening technology), antibody engineering (antibody humanization, affinity maturation, Fc Engineering) and antibody characterization (analytics and bioassays). In terms of biologics development service, GenScript ProBio has built a regulatory-compliant platform, from stable cell line development, host cell license, process development, analytical development to clinical manufacturing services, providing fed-batch and perfusion process to accelerate Investigational New Drug (“ IND ”) process and high quality material for clinical trials. GenScript ProBio has successfully delivered multiple Chemistry, Manufacturing and Controls (“ CMC ”) and Good Manufacturing Practice (GMP) manufacturing projects. GenScript ProBio’s total gene and cell therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
INFORMATION ON ABOGENBIO
Founded in early 2019, Abogenbio is a clinical innovative biomedical company focusing on the research and development of mRNA drugs and has a leading technology platform of mRNA and the nanometer delivery with independent intellectual property rights. Abogenbio has built up a multiple product pipeline covering the field of the prevention and treatment of infectious diseases and the immune oncology therapy.
INFORMATION ON WALVAX
Founded in 2001, Yunnan Walvax Biotech Co., Ltd.* ( 雲南沃森生物技術有限公司 ) (“ Walvax Yunnan ”) is mainly engaged in the research and development, manufacturing and distribution of safe and efficacious vaccines and is a recognized high-tech enterprise and an enterprise technology center. Walvax Yunnan was listed on the ChiNext of the Shenzhen Stock Exchange in November 2010 (stock code: 300142.SZ).
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Shareholders and potential investors of the Company are advised to pay attention to investment risks and exercise caution when they deal or contemplate dealing in the securities of the Company.
By order of the Board Genscript Biotech Corporation MENG Jiange Chairman and Executive Director
Hong Kong, 22 October 2021
As at the date of this announcement, the executive Directors are Mr. Meng Jiange, Ms. Wang Ye and Dr. Zhu Li; the non-executive Directors are Dr. Wang Luquan, Mr. Pan Yuexin and Ms. Wang Jiafen; and the independent non-executive Directors are Mr. Guo Hongxin, Mr. Dai Zumian, Mr. Pan Jiuan and Dr. Wang Xuehai.
- For identification purposes only
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