PD-1 safety, new crown and antibody research and development progress, etc. have been questioned the content of junshi response is false

On the same day after the publication of this article, Junshi Bio received an inquiry letter from the Shanghai Stock Exchange, asking Junshi to verify and disclose the relevant issues.
The Inquiry notes that the public article stated that Regency's Terriple monoclonal antibody injection (Toyi) "did not complete the trial of liver damage patients, nor did it complete the trial of patients with kidney damage, and the incidence of all adverse reactions was 97.7%.
15.6% of patients were permanently suspended due to adverse reactions.
" SSE requires Junshi: 1. Combined with clinical trial data, explain the specific meaning of "all adverse occurrences", verify whether the aforementioned reports are true, and supplement the disclosure of the progress of clinical trials of Ripley monoclonal antibody injections; Safety and effectiveness. 3. The Company achieved a cumulative operating income of RMB1,011 million in January-September 2020, an increase of 91.84% YoY. Please disclose the specific composition of operating income, such as product sales, patent licensing and technical services, and explain the reasons for the substantial increase in operating income during the reporting period.
In addition, in accordance with the announcement disclosed by Reshi Bio on May 6, 2020, the Company granted Lilly Pharma exclusive license for research and development activities, production and sales of its products JS016 outside Greater China, and Lilly Pharmaceuticals will pay the Company cash and sales share, and Lilly Pharmaceuticals may subscribe for the Company's newly issued H-shares for $75 million on mutually agreed terms and conditions.
has announced that it has discontinued clinical studies related to JS016, according to a public article.
SSE requires the Company to: 1. State the specific considerations relating to the share subscription terms in the JS016 authorized transaction with Lilly Pharmaceuticals, whether the relevant transaction arrangements are in accordance with general business logic, and 2. Disclose the progress of JS016 overseas clinical trials.
also includes a public article that says, "Junshi's research and development team is a college student with more than a Ph.D., most of them undergraduates, and the team and the company are led by a father and son with no biological background."
" SSE requested Junshi to supplement the disclosure of the specific composition of research and development personnel, the scientific research background of core technical personnel, as well as the recent changes in core technical personnel.
In the above-mentioned clarification statement, Jun Shi pointed out that "Ripley monoantigen in the second-line and above local progression or metastatic urethra cancer patients obtained an objective mitigation rate of 25.8%, PD-L1 positive population objective remission rate It reached 41.7%, with a total survival of 14.4 months in the overall population, and was the first anti-P in the world to complete a recurrence/metastatic nasopharyngeal cancer key registration and submit a listing application D-1 monoantigen; Terripri monoantigeni as a first-line treatment of advanced mucosal melanoma patients obtained an objective remission rate of 48.5%, and a disease control rate of 86.2%, with a medium progression-free survival period of up to At 7.5 months, the median total survival period was immature, 80% objective remission rate and 93.3% disease control rate were obtained in the combined treatment of intra-hepatic bile tube cancer, which was the best reported data of its kind, and in EGFR The objective remission rate of 50% and the disease control rate of 87.5% were obtained in the treatment of advanced EGFR mutant non-small cell lung cancer after TKI drug resistance.
" All of these clinical data are published in leading national and international academic conferences and journals, and this year, Ripley monoantigen was awarded three FDA-granted orphan drug awards in the treatment of mucosal melanoma, nasopharyngeal cancer, and soft tissue sarcoma.
Ripley's single-drug treatment for nasopharyngeal cancer has been recognized by the FDA as a breakthrough therapy (defined as preliminary clinical evidence that the drug may be substantially better at clinically important endpoints than existing therapies).
is also the first independently developed anti-PD-1 monoantigen in China to be recognized by the FDA's breakthrough therapy.
In addition, after the outbreak of the new crown outbreak, with the cooperation and support of many parties, Junshi JS016 successfully completed preclinical research on pharmacological toxicology, production process and pharmacodynamics, and passed the drug regulatory experts' rigorous scientific review, respectively, on June 5 and June 7 in China and the United States were approved for clinical research.
, JS016 has successfully completed two Health Subject Phase I studies in China and the United States.
, an international multi-center IB/II clinical study initiated by Jun Shi to evaluate the initial clinical efficacy and safety of JS016 among people infected with the new coronavirus is under way.
same time, JS016 is conducting a joint LY-CoV555 Phase II study (BLAZE-1, NCT04427501) initiated by Lilly Pharmaceuticals in the United States, and Lilly Pharmaceuticals announced the results of its in-period analysis on October 7, 2020, resulting in significant efficacy and safety data. The results of
combination therapy showed remarkable results in reducing viral load, reducing symptoms and reducing hospitalization and emergency treatment related to coronavirus, all reaching the preset NCT04427501 clinical primary and secondary endpoint, which is one of the few treatment options in various clinical programs worldwide to reach the full clinical end.
drug resistance variants were not observed in patients treated with combination therapy.
combination therapy has good tolerance and no serious drug-related adverse events (SAEs) have occurred, and sudden adverse events (TEAEs) in treatment are comparable to placebos.
adverse events (TEAEs) in combination therapy therapy were comparable to placebos.
Pharmaceuticals plans to file an emergency application in November.
Junshi said that the content of the relevant self-media articles completely contrary to objective facts, causing serious negative impact on the company, damage to the company's reputation.
company reserves the right to pursue liability by legal means.