Main points of investment
R & D expenditure continues to increase and cash reserves are sufficient: the company's total revenue in 2020 was 1.039 billion yuan, mainly due to licensing fees. The company's total loss in 2020 was 1.221 billion yuan, a decrease of 1.087 billion yuan compared with the same period last year, mainly due to revenue from licensing fees and making up for losses in the fair value of derivative financial liabilities, partly offset by an increase in sales expenses. Due to the promotion of the company's product pipeline, R & D expenditure increased from 1.396 billion yuan in 2019 to 1.405 billion yuan in 2020.
Platinib has been approved for sale, three drugs are about to be approved, and the harvest time has come: NMPA has approved Platinib for the treatment of adult patients with advanced or metastatic RET fusion positive NSCLC after platinum-containing chemotherapy. Atorvatinib was given priority in July 2020 and is expected to be the first accurate treatment for unresectable or metastatic GIST patients with PDGFRA exon 18 mutation in China. Shugli monoclonal antibody submitted its application for listing in November last year. The data of sulgarizumab used in the treatment of stage IV squamous and non-squamous NSCLC showed BIC potential in PD-1 and PD-L1 McAbs, and it was the only PD-L1 that combined chemotherapy was effective on both tissue subtypes of NSCLC. Avnib is the world's first new drug targeting IDH1 mutations, which has been approved by FDA for the treatment of adult patients with IDH1 mutant r AML. This product has been included in the "clinically urgent overseas New drugs list (the third batch)" by CDE, and the company expects to submit NDA to NMPA in the second half of this year.
Pipeline 2.0 continues to focus on global pioneering / best-in-class products in emerging therapies: through internal development and license-in, the company now has five potential FIC/BIC ADC drugs and multi-specific antibodies. Two of them are in the IND preparation stage. CS5001 is an ADC drug targeting ROR1 and a potential BIC molecule targeting a variety of tumors and hematological malignancies. CS2006 is a PD-L1x4-1BBxHSA trispecific antibody, which is a potential best 4-1BB agonist and the next generation of PD- (L) 1 inhibitors. As a potential new tumor immune backbone product, it provides a variety of combination therapy options.
Reach multi-dimensional cooperation with multinational pharmaceutical companies, in order to capture the huge market power: the company reached a multi-dimensional strategic cooperation with Pfizer Inc, Pfizer Inc injected capital into the company, acquired shares of the company and the right to commercialize PD-L1 Shugli in Chinese mainland area. The company has obtained two tumor products in the late research and development stage of Pfizer Inc pipeline and jointly developed rights and interests with Pfizer Inc in the Greater China region. Pfizer Inc's strong drug pipeline in the field of oncology will further enrich the company's pipeline layout. Deep cooperation from capital to pipelines can consolidate the company's long-term partnership with Pfizer Inc. In addition, the company has reached a global licensing agreement with EQRx, an American innovative biotech company. The company authorizes EQRx to develop and commercialize sulgarizumab and CS1003 (PD-1) outside Greater China to maximize the overseas commercial value of these two products through the company's innovative business model.
Our point of view: the company aims at the huge unmet medical needs of the high incidence of cancer in China, specializing in tumor immunization and precision treatment.
At present, the core products in the late clinical stage or BLA stage have significant differentiation, and the strategic cooperation with Pfizer Inc and other companies is expected to maximize the commercial value of the products. The commercial team has a size of about 200 people, covering 4 major oncology fields, more than 400 hospitals and about 100 cities. The dual-track mode of "self-construction" and "outsourcing" helps production. The planned production base of Suzhou Industrial Park with a total capacity of about 100000 square meters is expected to be completed by the end of 2021. After completion, the base will have integrated R & D capacity of R & D, pilot test and commercial production at the same time. Overall, the company's comprehensive capabilities in research and development, Becton Dickinson & Co, production, commercialization and other aspects continue to improve, it is suggested to actively pay attention to.
Risk hints: the sales of listed products are not as expected, the progress of research and development is not as expected, market competition is intensified, policy risks, and the impact of the epidemic exceeds expectations.
