I. Rorschach's tigit monoclonal antibody tiragolumab failed to reach the end point of MPFs in the first-line treatment of NSCLC combined with PD-L1 monoclonal antibody.
[comments] we believe that the successive failure of tiragolumab in SCLC and NSCLC clinical trials does not mean the failure of tigit target. We still need to observe different designs, different combination schemes and OS results. Moshadong, arcus / Gilead, Baiji Shenzhou (ASCO will release tigit / PD-1 / bevacizumab treatment data for HCC), Cinda biology, kangfang biology and other related products are under research. Yaoming biology may have 2-3 products in the tigit field, and we expect the long-term revenue to account for 1-2%.
2. FDA postponed the marketing application of Amicus Pompey's disease product pdufadate for 90 days to August 29, 22 to consider the newly submitted information, but did not require new clinical data,
[comments] Yaoming biology is the Pompeii disease product cdmo of Amicus. If the product is approved, it is expected to become a new commercial variety, waiting for the final review result.
III. caribou Biosciences disclosed its leading allogeneic cd19car-t data. Five patients with R / RB NHL, orr100% and cr80%. The company plans to release antler research data at the EHA meeting next month.
[comment] POC data of allogeneic car-t concept is expected to promote cell therapy to the next stage.
IV. AstraZeneca / Sanofi submitted new data to FDA on nirsevimab monoclonal antibody for RSV prevention and treatment. The phase III data of the product showed that it reduced the number of RSV related lower respiratory tract infections by 74.5%, but did not reach the secondary endpoint of reducing hospitalization rate. The result of the secondary endpoint may be affected by covid-19 epidemic.
[comments] the incidence of RSV infection in infants and young children is high, and there is a lack of effective RSV vaccine and drugs. In addition to AstraZeneca / Sanofi, GSK, Pfizer, Moderna and other products have entered the later stage of clinical trials. China's related fields are still blue oceans and sustainable attention.
V. Peter marks, head of the FDA vaccine, said that although the adult vaccine must achieve a protection rate of 50%, the vaccine for young children does not need to meet the same standard. The marketing applications of Moderna and Pfizer / biontech mRNA covid-19 vaccine for children under 5 years old are under approval.
[comment] all other adult and child vaccines currently approved in the United States have decreased the effect on Omicron, but they are still effective in reducing the risk of serious diseases, hospitalization and death.
