Summary of the company. Pioneering Pharmaceutical, founded in 2009 under the leadership of Dr. Tong Youzhi, is a biotech company focusing on the development of potential "best-in-class" and "first-in-class" drugs. After years of development, the company has built a product line with androgen receptor (AR) related diseases as the core, covering the global high incidence of cancer and other diseases that do not meet clinical needs, including COVID-19, prostate cancer, breast cancer, liver cancer, hair loss and acne.
The pipeline is rich and the competition pattern is good. The company has a diversified pipeline of small, macromolecular and combination therapies: six new drugs are undergoing clinical trials, including androgen receptor (AR) antagonists, ALK-1 monoclonal antibodies, mTOR inhibitors, Hedgehog/SMO inhibitors and AR-Degrader;, as well as PD-L1/TGF- β double antibodies and c-Myc inhibitors in preclinical studies. The competition pattern of these products is good, and most of them adopt the strategy of "double newspaper" between China and the United States, which has the potential to realize internationalization in the future.
With more blossoms in the field of AR, COVID-19 / hair loss / acne indications are expected to bring 10 billion sales potential. The company's core product, AR antagonist Puclosamide, is expected to complete the first-line and final-line III clinical trials of prostate cancer in 2021, and submit an application for listing, which is expected to become the first domestic AR antagonist new drug, with a sales peak of 2 billion yuan. At the same time, the company has beautiful clinical III phase data for mild and severe cases of new crown carried out by the company in Brazil, and has launched clinical III phase in the United States, which is expected to obtain data in mid-2021, which has the potential to become an oral specific drug for COVID-19. The II clinic for androgenic alopecia has been completed, and the data are expected to be disclosed in Q3 in 2021. The I/II phase clinical for acne is being enrolled, the drug is high, and the target groups of indications are more than 100 million, with clear consumer goods attributes, and the market potential is expected to reach 10 billion.
It is expected that the catalyst will continue in the next six months, and the value of the company is expected to increase significantly. With the continuous progress of the clinical progress of the company's products, we expect to usher in the following important catalysts for the development of the pharmaceutical industry: the rPFS data of the first-line mCRPC and the reported production of Pucloidomide; the OS data of the mCRPC of the last line of Pucloidomide to decide whether to report for production; the II data of Freitane in the treatment of androgenic alopecia; and the completion of the indications for acne. Puclosamide US new crown mild disease, severe data, and potential overseas cooperation and sales. Where:
The success of the first-line mCRPC of proclomide is a high probability event; according to the clinical results and registration path of claccodone, Freitaan has a high success rate, and hair loss and acne are both facing the consumer market of 100 million people, so there is a lack of effective treatment in the whole field; COVID-19 indications of prolamide have beautiful mild and severe data in Brazil, and the clinical success rate of phase III in the United States is high, so it is expected to become an oral specific drug against novel coronavirus.
Profit forecast, valuation and investment rating. From 2020 to 2022, we estimate that the return net profit of the company will be-2.65,- 3.30,- 197 million yuan respectively, and the corresponding EPS will be-0.72, 0.89, 0.53 yuan, respectively. As COVID-19 and prostate cancer indications enter the approval stage, the company is expected to begin to enter the commercial stage in 2021, giving the company a target price of 38.50 yuan according to risk-adjusted pipeline DCF estimates. Cover for the first time, giving a "push" rating.
Risk hint: clinical trials of new drugs have failed.