The company announced its semi-annual report for 2021: revenue of 12.97 million yuan, an increase of 396.17% over the same period last year; R & D expenditure of 318 million yuan, an increase of 26.28% over the same period last year; bank balance and cash of 1.103 billion yuan; and a loss of 377 million yuan, an increase of 18.02% over the same period last year. The company has no products on the market yet, and its income comes from the intellectual property license fees paid by UNITY Biotechnology. The performance is in line with our expectations.
Clinical development has been promoted in an all-round way, with significant advantages in clinical data: the company has 8 clinical drug candidates and has conducted more than 40 clinical trials in China, the United States, Australia and Europe. Among them, 7 clinical developments were presented at the AACR annual meeting, and 4 clinical developments were presented at the ASCO annual meeting, including two oral reports from APG-2575 and APG-115. The objective remission rate of Bcl-2 selective inhibitor APG-2575 in the treatment of patients with recurrent / refractory chronic lymphoblastic leukemia / small lymphocytic lymphoma was 80.0%, and the safety advantage was obvious, no clinical or laboratory tumor lysis syndrome was reported, no dose-limited toxicity was observed, and had the potential of "best-in-class". MDM2-p53 inhibitor APG-115 combined with pablizumab in the treatment of PD- (L) 1-resistant melanoma patients with an objective remission rate of 24.1%, disease control rate of 55.2%, is expected to overcome the existing immune tumor drug resistance problem, with "first-in-class" potential. Solid clinical data have laid the foundation for the steady development of the company.
Reached a significant strategic cooperation with INNOVENT BIO to accelerate the commercialization of the company: the company reached a strategic cooperation of US $245 million with INNOVENT BIO on the joint development and promotion of HQP1351 in the Chinese market and the clinical cooperation and joint development of APG-2575 in the Chinese market. INNOVENT BIO's rich macromolecular product line and Yasheng Pharmaceutical's small molecular drug research and development experience complement each other, and accelerate the expansion of new product indications by sharing clinical development experience. and can make full use of INNOVENT BIO's strong commercial team in the field of hematology and oncology to achieve wider market coverage. In addition, the company reached a collaborative research and development agreement with the National Cancer Institute (NCI) to jointly develop Bcl-2/Bcl-xL inhibitor APG-1252 to maximize the clinical potential of APG-1252 in the treatment of solid tumors. Extensive strategic cooperation also reflects the market recognition of the company's R & D and innovation capabilities.
The core variety HQP1351 has been included in the "breakthrough therapeutic variety" and is about to be put on the market: the third generation tyrosine kinase BCR-ABL inhibitor HQP1351 has submitted a NDA application to NMPA in June 2020, and won the priority review of CDE. In March 2021, it will be awarded as a "breakthrough therapeutic variety" by CDE again, which will further speed up the review and listing, and is expected to be conditionally approved for listing in China in the second half of 2021. By working with Cinda's mature commercial team, it is expected to infiltrate 80 per cent of the CML market before entering health insurance, increase peak HQP1351 sales and maximize the commercial value of drugs.
Profit Forecast and Investment rating: as the company's products are listed and sold, revenue will grow rapidly. We maintain the estimated operating income of 0.38 yuan, 219,759 million yuan and EPS of-2.59 yuan,-2.86 yuan,-2.57 yuan respectively in 2021-2023, maintaining the "buy" investment rating.
Risk hints: the R & D and clinical progress is not as expected, and the uncertainty of the technology platform.