Why Choose Junshi Biological Cooperation? Eli Lilly says science and data factors bear the brunt

Original title: Why choose Junshi Biological Cooperation? Eli Lilly says science and data factors bear the brunt

Summary

[Perché scegliere Junshi Biological Cooperation? Eli Lilly ha affermato che la scienza e i dati sono i primi a sopportare il peso]On the evening of November 12, Junshi Bio (688180, SH) received an inquiry letter from the Shanghai Stock Exchange. Among them, the Shanghai Stock Exchange mentioned: “The public issue article states that Eli Lilly Pharmaceuticals has announced that it has stopped clinical research related to JS016.” Therefore, the Shanghai Stock Exchange requested Junshi Bio to explain specific considerations regarding the terms of subscription of shares in the JS016 authorized transaction with Eli Lilly. , If the relevant transaction agreements comply with general business logic and disclose the progress of the overseas clinical trial JS016. (Daily Economic News)

On the evening of November 12,Junshi Bio(688180, SH) received a letter of inquiry from the Shanghai Stock Exchange. Among them, the Shanghai Stock Exchange mentioned: “publicAccording to the article,Eli LillyThe pharmaceutical company announced that it has stopped clinical trials related to JS016. “Therefore, the Shanghai Stock Exchange requiresJunshi BioDescription eEli LillyPharmaceutical in JS016AuthorizationRelated in the transactionActionsSpecific consideration of the terms of underwriting and whether the related transaction agreements are in line with the general conditionsbusinessRationale and disclose the progress of clinical trials overseas JS016.

November 13Eli LillyThe reporter told the Daily Business News that science and data were the first reasons for choosing Junshi as a partner.

Image source:Hong Kong stocksJunshi BioBeforeadScreenshot

　　Cooperative research and developmentNew corona neutralizing antibody

　　Industrial securitiesResearch reportNeutralizing antibodies have been shown to have a dual role of prevention and treatment and should become “specific drugs” for the new crown. Currently worldwideTo share12 designs of neutralizing antibodies entered the clinic. Including Eli Lilly and Canada AbCellerathe companyThe jointly developed LY-CoV555 neutralizing antibody. Currently, LY-CoV555 has entered Phase III clinical trials for prevention and clinical trials for treatment.

Among domestic companies, Junshi Biotechnology and the Chinese Academy of Sciences Institute of Microbiology jointly developed JS016, which has become the first and second coronavirus neutralizing antibody therapy in China to enter clinical trials.

On May 4, 2020, Junshi Biotech (01877, HK) announced that the company has partnered with Eli Lilly to develop and commercialize new corona neutralizing antibody drugs.ProductCodename is JS016 (or LY-CoV016) Eli Lilly will have access to clinical development, manufacturing and marketing of products outside of ChinaExclusive license。

Under the agreement, Eli Lilly will pay Junshi Bio 10 millionU.S. dollarfirstpaymentAnd after each new Junshi corona antibody (disposable or combined) reaches the required milestone event, it will pay Junshi Biologics a key payment of up to US $ 245 million, plus theSales of productsTwo-digit net percentageSalesDivided.

Additionally, Eli Lilly plans to spend $ 75 million to subscribe to Junshi Biotech’s new H shares (potential subscription), but at that time a formal underwriting agreement was still pending for potential subscription.

Regarding why he chose to partner with Junshi, Eli Lilly said: “He sent interdisciplinary experts beforeteamThorough evaluation of all data from Junshi Biology JS016 project, including pharmacology, toxicology, pharmacokinetics, CMC (pharmaceutical research), etc. At the same time, it also conducted two rounds of on-site investigations on Junshi’s two large-scale production bases , including the production of antibodies.Craft, QC system and team. “

In June 2020, JS016 initiated clinical trials in China and the United States. Clinical trials in China were conducted by Zhang Jing of Fudan University Huashan Hospital.ProfessorConducted in collaboration with Professor Zhang Wenhong. At the recent CIIE, Eli Lilly also told the media, including the “Daily Business News”, that current clinical trials of JS016 in China, the United States and other countries have entered phase II and that the first phase will be completed on 7 June. Administered to 1 patient and completed all dosing groups on 7 July. The current Phase I clinical trial has been successfully completed. Research data shows that JS016 is safe and well tolerated.

On October 7, Junshi Biopharmaceuticals made an announcement: Eli Lilly is expected to submit an Emergency Use Authorization (EUA) application for combination therapy of LY-CoV555 and JS016 in November 2020, and Eli Lilly is expected to obtain it as early as the second. quarter of 2021 Data and submit an application for a biological product license (BLA) for combination therapy.

　　The suspended trial period does not apply to products that Eli Lilly and Junshi have collaborated with

Currently, Eli Lilly has two new coronavirus neutralizing antibodies, namely LY-CoV555 and JS016 mentioned above.

On October 19, Eli Lilly disclosed independent data security monitoringCommittee(DSMB) It is recommended that enrollment in the ACTIV-3 study be suspended. ACTIV-3 was initiated by the National Institutes of Health (NIH) to evaluate the efficacy of Eli Lilly’s research neutralizing antibody LY-CoV555 combined with Redecivir in hospitalized patients with more severely severe COVID-19.

On November 9, the FDA approved the emergency use clearance of LY-CoV555 (700 mg) for the treatment of adults at risk of developing a severe and / or inpatient new coronavirus, as well as patients over the age of 12 years diagnosed with new coronary pneumonia.

In other words, Eli Lilly has suspended the clinical trial of LY-CoV555 combined with Redecivir for hospitalized patients with new severe coronary pneumonia, but LY-CoV555 as a single agent for the treatment of patients with mild to moderate new coronary pneumonia was authorized. by the US FDA.

Why has the clinical trial of the combination of LY-CoV555 and Remdesivir been suspended?

On November 13, Eli Lilly explained in response to the “Daily Business News” reporter: For critically ill patients with new coronary pneumonia, antibody therapy has little effect at this time. Due to the long period of infection and severe symptoms, the patient has already produced endogenous antibodies. In addition to checking for antibodies, the patient may have other inflammatory reactions and multiple organ failure. At this time, the drug will not be able to control other symptoms.

Image Source: Junshi Bio Response Announcement Screenshot

Additionally, Eli Lilly is also conducting research on BLAZE-2 and ACTIV-2 for antibody therapy for new coronary pneumonia. BLAZE-2 is used for LY-CoV555longA Phase III clinical study on the prevention of new coronary pneumonia conducted by residents and employees of medical care institutions. The ACTIV-2 study is a study of LY-CoV555 used in mild to moderate patients who have recently been diagnosed with new coronary pneumonia.

(Source: Daily Economic News)

(Responsible publisher: DF524)