Securities code: 688180 securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022-002 Shanghai Junshi Biosciences Co.Ltd(688180)
With regard to the progress announcement of signing the license and commercialization agreement with coherus, the board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
On February 1, 2021, Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as "the company") and coherus Biosciences, Inc. (hereinafter referred to as "coherus") signed the exclusive license and commercialization agreement (hereinafter referred to as "the license and commercialization agreement"). According to the license and commercialization agreement, the company will grant the exclusive license of coherus treprizumab and two optional projects (if implemented) in the United States and Canada (hereinafter referred to as "coherus region"), as well as the priority negotiation right of two early-stage checkpoint inhibitor antibody drugs, and can obtain a total down payment of up to US $1.11 billion Optional project execution fee and milestone payment. The matter was disclosed on the website of Shanghai Stock Exchange on February 2, 2021 (Announcement No.: pro 2021-006).
On January 10, 2022, through consultation between the company and coherus, coherus has started the procedure to exercise the option of recombinant humanized anti tigit monoclonal antibody (project code: js006), one of the optional projects, so as to obtain the license to develop js006 or any product containing js006 in coherus area for the treatment or prevention of human diseases. On the premise of complying with applicable laws and meeting the conditions agreed in writing by both parties, according to the license and commercialization agreement, coherus will pay the company a one-time execution fee of US $35 million, which is non refundable; After reaching the corresponding milestone event, coherus will pay the company a milestone payment of no more than US $255 million, plus any sales share including 18% of the annual net sales of js006 products in coherus region.
Risk tip: due to the long R & D cycle and many approval links of drugs, it is vulnerable to some uncertain factors. There is a certain risk whether js006 can be successfully approved for listing in coherus region. In addition, the execution fee agreed in the license and commercialization agreement shall be implemented after complying with applicable laws and meeting the conditions agreed in writing by both parties. The milestone payment shall meet certain preconditions. The final payment amount and its impact on the company's future operating revenue and profit are uncertain.
1、 Progress overview
On February 1, 2021, the company signed a license and commercialization agreement with coherus. According to the license and commercialization agreement, the company will grant the exclusive license of coherus treprizumab and two optional projects (if implemented) in coherus area, as well as the priority negotiation right of two early-stage checkpoint inhibitor antibody drugs, and obtain a total down payment, optional project implementation fee and milestone payment of up to US $1.11 billion. For details, please refer to the announcement on the website of Shanghai Stock Exchange on February 2, 2021 (Announcement No.: pro 2021-006).
On January 10, 2022, through consultation between the company and coherus, coherus has started the procedure of exercising the option of js006, one of the optional projects, in order to obtain the license to develop js006 or any product containing js006 in coherus area for the treatment or prevention of human diseases. On the premise of complying with applicable laws and meeting the conditions agreed in writing by both parties, according to the license and commercialization agreement, coherus will pay the company a one-time execution fee of US $35 million, which is non refundable; After reaching the corresponding milestone event, coherus will pay the company a milestone payment not exceeding US $255 million in total, plus any sales share including 18% of the annual net sales of js006 products in coherus region (hereinafter referred to as "this cooperation").
Js006 is a specific anti tigit monoclonal antibody injection independently developed by the company. Preclinical studies showed that js006 could specifically block tigit-pvr inhibitory pathway, stimulate the activation of killer immune cells and secrete tumor killer factors. Anti tigit antibody and anti-PD-1 / PD-L1 antibody show synergistic anti-tumor potential. The combination of the two is a promising anti-cancer treatment strategy, which is expected to increase the response of patients to immunotherapy and expand the range of possible beneficiaries. As of the disclosure date of this announcement, the clinical trial application of js006 has been approved by the State Drug Administration and the U.S. Food and drug administration respectively. A phase I clinical study of dose escalation and dose expansion (nct05061628) is ongoing to evaluate the safety, tolerance and pharmacokinetics of js006 alone and in combination with treprizumab in patients with advanced tumors.
2、 Impact on the company
This cooperation will further consolidate the strategic cooperation relationship between the company and coherus in the field of tumor immunotherapy, accelerate the overseas clinical development and market development of js006, and both parties are planning to carry out the later clinical trial of js006 combined with treprizumab in North America to evaluate the potential of js006 combined with treprizumab, Provide patients with high-quality and effective treatment options. This cooperation will broaden the business layout of the company's products in the field of tumor treatment in overseas markets, enhance the company's commercialization competitiveness in the global market, comply with the company's international strategic development plan, and is expected to have a positive impact on the company's sustainable operation.
3、 Risk tips
According to the data published in clinical development success rates 2006-2015, for antitumor drugs, the general phase I / II clinical research phase lasts for about 2 years. The rate of phase I entering phase II is about 62.8%, and the rate of phase II entering phase III is about 24.6%. Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the drug has a long cycle and many links from development and clinical trial approval to production, which is vulnerable to some uncertain factors. Finally, there is a certain risk whether js006 can be successfully approved and listed in coherus area. In addition, the execution fee agreed in the license and commercialization agreement shall be implemented after complying with applicable laws and meeting the conditions agreed in writing by both parties. The milestone payment shall meet certain preconditions. The final payment amount and its impact on the company's future operating revenue and profit are uncertain. Please make careful decisions and pay attention to preventing investment risks.
The company will actively promote the above cooperation with coherus and timely fulfill the obligation of information disclosure on the follow-up progress of the project in accordance with relevant regulations. The company's information shall be subject to the announcements published in China Securities Journal, Shanghai Securities News, securities times, securities daily and the website of Shanghai Stock Exchange. It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors January 11, 2022
