U.S. pharmaceutical Eli Lilly is partnering with Chinese drugmaker Shanghai Junshi Biosciences to develop new antibody therapies for COVID-19, the disease that has sickened 3.6 million people worldwide.
The companies will collaborate on therapeutic antibody research that could be used to treat and prevent SARS-COV-2, the virus that causes COVID-19, Hong Kong listed Junshi said in a statement. The deal is worth up to $330 million to Junshi.
As scientists race to develop treatments for COVID-19, neutralizing antibody therapies seem to be in the forefront due to their potential efficacy, despite substantial risks, experts say.
A neutralizing antibody recognizes proteins on a virus and blocks them from binding with cell receptors. Unlike vaccines, which use antigens to induce the human body to produce antibodies, neutralizing antibody treatments are directly injected.
"Entering into this agreement with Lilly empowers us to accelerate the clinical development of Junshi SARS-CoV-2 antibodies globally," said Junshi CEO Li Ning.
Lilly will first pay Junshi $10 million, followed by up to $245 million in subsequent installments when specific metrics are achieved, such as obtaining regulatory approval and showing progress in clinical trials. Lilly will also pay more than 10% of net sales to Junshi, according to the agreement.
Lilly also agreed on a potential share placement deal, in which it will buy $75 million of newly issued Junshi shares in Hong Kong. The transaction is pending the signing of a formal agreement.
Under the partnership, Lilly will be granted exclusive rights for clinical development, manufacturing and distribution of new therapies outside the Chinese mainland, Hong Kong, Taiwan and Macau, while Junshi will maintain all rights within the region.
The companies aim to submit an Investigational New Drug application to U.S. regulators and initiate clinical studies in the U.S. in the second quarter of the year, according to Junshi. The company did not provide a timeline for trials in China.
While the dramatic drop of COVID-19 patients in China makes in-country trials more difficult, testing in the U.S. will be easier because of the large number of patients.
Scientists are exploring therapeutic antibodies, as they can specifically target a virus and be highly effective, medical experts say. However, such therapies carry risks. Researchers have found that some antibodies may induce a cytokine storm -- an excessive immune response that ravages healthy lung tissue, leading to acute respiratory distress and multi-organ failure.
Junshi started studying antibody therapies for COVID-19 at the start of the year and developed multiple neutralizing antibodies. One of the most promising projects is JS016, an antibody specific to the SARS-CoV-2 surface protein receptor, which can block binding to the host cell. The project is a joint development between Junshi and the Chinese Academy of Science.
JS016 has completed pre-clinical studies and is now poised to start clinical testing.
"The data generated by Junshi suggests the lead antibody may have appropriate properties to support testing its therapeutic use in patients as well as exploring its potential for preventing infection in at-risk individuals," said Daniel Skovronsky, Lilly's chief scientific officer. "We look forward to partnering with Junshi to quickly begin testing this potential new therapy in clinical trials."
Yao Sheng, deputy general manager of Junshi, said earlier the company is in discussions with global regulators to push forward potential clinical trials for two of its neutralizing antibodies engineered for COVID-19.
An informed source said the partnership with Lilly will help Junshi accelerate clinical studies, and also fits into Lilly's strategy of improving antibody studies.
Lilly devoted just six days of due diligence on Junshi's capacity for production, as well as research and development, while offering unusually good terms, including a high double-digit share of sales for Junshi, the person said.
Denise Jia contributed to this story.
Read also the original story.
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