Event comments:
Recently, CDE issued a notice on publicly soliciting opinions on the guiding principles for clinical research and development of bispecific antibody antitumor drugs. For BsAb targeting multiple epitopes, due to the particularity of structure and function, it puts forward detailed specifications for safety and effectiveness in clinical development
Request.
Guided by clinical needs and aiming at solving problems that cannot be solved by McAb
Reasonable research topics should be carried out on the basis of relatively mature single target / McAb research, so as to fully explore the clinical advantages of BsAb over McAb products and McAb combination. Due to the structural complexity of BsAb, it has a more unique mechanism of action, and the process is more complex, which may also lead to more potential safety problems of single drug or combination. Therefore, in the development of BsAb, unless a new mechanism is generated through the structure of BsAb, if any target has monoclonal resistance, it may be necessary to carefully consider the necessity and rationality of developing BsAb.
In principle, the control group selected the best SOC containing any single monoclonal antibody with the same target in BsAb
In the opinion draft, the selection of the control group is refined. In addition to selecting the optimal standard treatment according to the general tumor drug R & D requirements, in order to improve the effectiveness of the existing treatment, it is proposed that the refinement principle is based on the corresponding monoclonal antibody. The current optimal SOC of the same indication already contains any single or combined monoclonal antibody of the same target in BsAb, and the SOC containing the monoclonal antibody should be selected in the control group.
Investment advice
The clinical guidance on double antibodies is a further refinement of the tumor subdivision field after the release of the guiding principles for tumor clinical research in July 2021. The mechanism of double antibody is unique, and the research on the underlying mechanism needs to be further explored. With the successful listing of several BsAb drugs, the development of BsAb drugs has entered a stage of rapid development. At present, 698 clinical projects have been carried out in China. We believe that with the introduction of standardized clinical guidelines, effective resources have been reasonably allocated and the competition pattern has been significantly optimized.
The investment idea under the post epidemic situation should return to the industrial operation trend and grasp the two main investment lines of bottom process innovation and cutting-edge scientific and technological innovation.
1. The main line of bottom process innovation: the invisible champion at tob end. It is suggested to pay attention to the opportunities of individual stocks in the upstream equipment, gene consumables, biological enzymes, high-end analytical instruments and reagents of the biopharmaceutical industry chain
2. The main line of cutting-edge scientific and technological innovation: the value of cutting-edge technology platform. It is suggested to pay attention to the potential investment opportunities of ADC, shuangkang and mRNA technology platform companies.
In the medium and long term, the industry has ushered in the historical opportunity of transformation and upgrading. In the short term, it has fluctuated under the influence of the external macro environment and sentiment. In the long term, we maintain the overweight rating of the industry.
Risk tips
The clinical research and development of innovative drugs failed, and the pharmaceutical procurement policy continued to be under high pressure
The internationalization process is slow.
