Events
1. On February 22, CDE issued the working procedures of the drug review center for accelerating the review of innovative drug listing applications (Trial) (Draft for comments), and the time limit for comments is two weeks from the date of publicity. It is worth noting that the scope of application of the working procedures is defined as innovative drugs included in the breakthrough treatment drug procedure, and it is clear that the time limit for communication and exchange is 30 days, and the time limit for variety review is 130 days compared with that for priority review. This opinion draft is slightly beneficial to China's innovation industry.
2. Fdapdufa of legendary biological core product sidaki Orense is expected to be held on February 28 local time in the United States. If passed, it will become the second bcmacart in the world. This product is used to treat adult patients with relapsed and / or refractory multiple myeloma (mm). It has completed 97 key clinical trials in China and the United States, and has the potential to become a global bestinclass heavyweight variety.
Key investment points
Legendary creatures are expected to become a breaker of China's internationalization at sea. Since the self-confident bio PD-1 was blocked in the FDA approval, the focus of the market has shifted to the legendary bio bcmacar-t sidakiolensea. The main reason is that at present, China's innovative drug market is actually very sensitive to the approval attitude of FDA. Cinda biological PD-1's metoo attribute and the use of single national data for approval is itself a "shortcut", which has not fundamentally damaged the core logic of China's innovative drug enterprises going to sea. Legendary bio's xidakiolensea also experienced some twists and turns while waiting for FDA approval. As early as April 2021, Johnson & Johnson / legendary bio had completed the rolling submission of xidakiolensea's BLA application to FDA, and FDA would have given the approval results in November of that year; However, in November, the approval was delayed by the US FDA, and the final approval date was adjusted to February 28 this year. The approval delay may be due to the delay of the review procedure caused by the covid-19 epidemic.
The quality of global multicenter clinical data is good and the probability of approval is high. At the end line of legendary biotherapy for mm, the primary endpoint orr / (s) Cr was 98% / 83%, which was significantly superior to that of Bluebird bcma-cart72% / 39% approved by FDA; MPFs was more than 2 years, which was higher than that of similar therapies for an average of 8-12 months; The incidence of cytokine storm / neurotoxicity above grade 3 was 5% / 10% and Bluebird 9% / 4%, which was safe and controllable. In the n = 97 treatment group, white / Black / Asian / other were 69% / 17% / 3% / 10%, close to the racial composition of the United States. In conclusion, it is expected that legendary biological cart has passed the clinical trial design approved by FDA and excellent product strength, with a great probability of approval.
Or will boost the heat of the cell therapy industry. At present, six car-t therapies have been approved to market all over the world. Except for abecma of BMS / Bluebird targeting BCMA, the other five approved products target CD19. According to the clinical data, sidaki orenser, a legendary creature, is better than its peers. From 2019 to 2021, the global car-t market grew rapidly, with us $734 million, US $1081 million and US $1.709 billion respectively. According to fro Sullivan's prediction, the compound annual growth rate of the industry is expected to be as high as 55% from 2019 to 2024, and the global market scale will reach US $6.6 billion in 2024. There is a broad market space in this field. Legendary biology signed an agreement with Johnson & Johnson in 2017. According to the cooperation terms reached between legendary biology and Janssen, legendary biology has received an advance payment of US $350 million and a milestone payment of US $250 million; In terms of profit distribution after commercialization, legend biology and Janssen have a 50 / 50 distribution agreement on overseas interests. At the end of 2021, Johnson & Johnson said that the peak value of the product could reach US $5 billion.
Investment suggestion: 2022 is the first year for the internationalization of innovative drugs in China. At present, many enterprises (Xinda, legend, Junshi, Baiji, Hehuang, Hengrui and Yifan) have submitted NDA in the United States, with the largest number in history. In the early stage, the overseas listing of Cinda biology PD-1 was blocked, which affected the market's investment sentiment for innovative drugs to go to sea. If the legendary biology is approved this time, it is expected to boost the international logic and cell therapy industry chain of head innovative pharmaceutical enterprises.
Risk factors: the approval progress is less than expected; International political risks;
