Junshi Biotechnology was questioned by the Shanghai Stock Exchange about the new crown neutralizing antibody in collaboration with Eli Lilly

Original title: Junshi Biologics was interrogated by the Shanghai Stock Exchange, involving the new crown neutralizing antibody in collaboration with Eli Lilly

On the evening of November 12, ShanghaiJunshi BiomedicinalTechnological actionsLimited copiesthe company(Junshi Bio, 688180) releasedadHe said the same day he received theJunshi BioStocks of pharmaceutical technologyLimited Liability CompanyInquiry letter reported by relevant media “(” Inquiry letter “for short).

In the “Letter of Request”, the Shanghai Stock Exchange asked Junshi Bio to provide a WeChat accountpublicNo. Related articles published related to the company’s core businessProduct4 main issues are verified and disclosed such as research and development capabilities.

First, the safety of the Teripril (Tuoyi) monoclonal antibody injection of the Junshi Biologics product.

The public issue article stated that Junshi Bio’s injection of the monoclonal antibody Teripril (Tuoyi) “inTechnical reviewIn the document, neither the experimentation on a patient with liver damage nor that on a patient with renal damage has been completed. The incidence of all adverse reactions was 97.7% and 15.6% of patients permanently discontinued the drug due to adverse reactions. “

Shanghai Stock Exchange requests Junshi Bio to provide three responses, including combining clinical trial data, explaining the specific meaning of “all adverse incidence rates”, verifying the veracity of the previous report, and integrating the disclosure clinical trials on teripril monoclonal antibody injection Company progress; combining their products andmarketRelevant experimental data from similar products in the same category illustrate the safety and efficacy of Teripril monoclonal antibody injection; the company achieved cumulative results from January to September 2020Operating income 1.011 billion yuan,Year after yearAn increase of 91.84%, please indicate the specific composition of operating income, such asSales of products, Patent License eTechnical servicesThe proportion of other categories and explainsrelationshipThe reason for the substantial increase in the operating result in the period.

　　Second, the new corona neutralizing antibody JS016 eEli LillyCooperation details.

The “Inquiry Letter” stated that the public account article stated soEli LillyThe pharmaceutical company announced that it has stopped clinical research related to JS016. It explains two aspects of the problem, including the explanation andEli LillyPharmaceutical in JS016 AuthorizationSpecific considerations regarding the terms of the subscription of shares in the transaction and whether the transaction in questionbusinessLogic; disclose the progress of clinical trials overseas JS016.

Third, Junshi Biological Research and Developmentteamconstitute.

The public issue article stated that “Junshi’s R&D team is more of an undergraduate than a PhD, and most are a graduate team. The leaders of this team and this company are a couple. of father and son without any training in biology “. In this regard, the Shanghai Stock Exchange requires Junshi Bio to supplement the disclosure of the specific composition of research and development personnel.Core technologyThe scientific research background of the personnel and the recent changes in the basic technical personnel.

Fourth, the Shanghai Stock Exchange requires sponsors to check the above issues one by one and to make a clear statement about the authenticity of the disclosed content.opinion。

According to the “Letter of Inquiry”, Junshi Biotech was required to disclose this inquiry letter on November 12th and disclose her response to the inquiry letter before November 19th.

Junshi Biotech said the company will actively organize all parties to respond to the issues involved in the “Letter of Request” and fulfill information disclosure obligations in a timely manner in accordance with the requirements of the Shanghai Stock Exchange. PleaseinvestmentFollowersCompany announcement, Pay attention to investment risks.

Junshi Bio was founded in 2012 and was successfully listed on the main board of the Hong Kong Stock Exchange on December 24, 2018. On May 20, Junshi BioCommittee for scientific and technological innovationThe registration of the initial public offering of shares resulted in “A + H”.

According to information from the official website, Junshi Bio is an innovation-driven biopharmaceutical company. Its pipeline of products under research includes 16 innovative drugs and 1 biosimilar, mainly covering tumor immunotherapy, autoimmune diseases, cardiovascular and osteoporosis, etc. In the field of major diseases, many products are the first major domestic innovative monoclonal antibodies to gain clinical approval, including the PD-1 monoclonal antibody (JS001) for tumor immunotherapy and PCSK9 for the treatment of hypercholesterolemia Antibody monoclonal (JS002), BLyS monoclonal antibody (UBP1213) for the treatment of systemic lupus erythematosus, of which JS001 has been placed on the market.

(Source: The Paper)

(Responsible publisher: DF524)