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海创药业(688302):创新管线稳步推进 核心产品商业化在即

Haichuang Pharmaceutical Industry (688302): innovation pipeline steadily promotes the commercialization of core products.

財通證券 ·  Aug 31, 2022 00:00  · Researches

Event: the company's 22H1 has no product sales revenue for the time being and has not yet made a profit. The net profit belonging to the shareholders of the listed company is-148 million yuan, and the net profit attributed to the shareholders of the listed company after deducting is-164 million yuan, which is basically the same in the same period.

IPO raises funds to enrich the company's cash on hand, which will help to support the smooth progress of the follow-up pipeline. As of 22H1's total assets of 1.836 billion yuan (+ 86.90%), the owner's equity belonging to the parent company was 1.689 billion yuan (+ 114.15%), mainly due to the actual net inflow of 995 million yuan after the company raised funds in the first public offering. On the expense side, the company's R & D expenditure is 122 million yuan (- 4.95%), and all of them are expense expenses; the management expenses are 46 million yuan (+ 28.56%), mainly due to an increase of 7.3211 million yuan in share payment fees for the implementation of equity incentives and an increase in labor costs for new personnel compared with the same period last year.

The variety of core new drugs is advancing steadily, and HC-1119 is expected to submit NDA this year, which is expected to fill the gap in the second-line treatment market after mCRPC drug resistance. The company has 10 innovative drug research projects, and the core product HC-1119 has reached the main end point after being reviewed by the independent data monitoring committee in June this year, and has submitted a pre-listing communication application to the CDE Drug Review Center, while actively carrying out commercial team building. HC-1119 is expected to be the first domestic innovative drug approved for the treatment of mCRPC after abirone / chemotherapy, addressing the unmet clinical needs of patients. Clinical studies of other core varieties are also progressing steadily: gout drug HP-501 is carrying out preparations for phase III clinical trials in China; CD44v6 inhibitor HP558 has completed phase I clinical trials in Europe and has been approved to conduct phase II clinical trials in China; and the phase I trial of domestic oral AR targeted PROTAC molecule HP518 in Australia is smoothly advancing the dose climbing trial as planned.

Profit forecast and valuation: from 2022 to 2024, it is predicted that the company will achieve 0, 0, 636 million yuan in revenue,-4.70,7.82,- 308 million yuan in net profit, and-7.90,3.11yuan in EPS-4.75.

Risk tips: clinical progress is not as expected; the speed of new drug review is not as expected; the commercialization of products is not as expected.

The translation is provided by third-party software.


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