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科兴制药(688136):丰富的海外商业化经验助力中国新药出海 持续加入研发投入推进新药项目

Kexing Pharmaceutical (688136): Rich overseas commercialization experience helps China's new drugs go overseas and continue to invest in R&D to promote new drug projects

信達證券 ·  Sep 7, 2023 00:00

Event: the company recently released its 2023 semi-annual report, with revenue of 649 million yuan (yoy+3.11%) in the first half of 2023, net profit of-48 million yuan (2022H1 + 3 million yuan) and non-return net profit of-72 million yuan (2022H1 + 3 million yuan).

Comments:

Continue to increase investment in R & D, affecting profit performance

2023H1 R & D investment totaled 195 million yuan (yoy+145.28%), accounting for 30% of revenue, of which fee-based R & D investment was 124 million yuan, an increase of 56.59% over the same period last year, an increase of 44.93 million yuan, financial expenses of 13.49 million yuan, 2022H1 of 4.18 million yuan, an increase of 223% over the same period last year, mainly due to an increase in the balance of loan stock and the corresponding increase in interest expenses, so the net profit of returning home is a loss of 48 million.

Over the past 20 years of overseas commercial experience, the company has introduced a total of 8 products, including albumin paclitaxel, bevacizumab, infliximab, adamumab, lialurutide injection, trastuzumab, nelatinib maleate and lenalidomide, which have formed a rich product mix. The company has been going to sea for 20 years, has established a relatively complete overseas business system, and has accumulated rich resources and commercialization capabilities in overseas product registration, overseas development and marketing, overseas GMP compliance audit, etc., and has achieved market access and sales through market access in about 40 countries and regions, including Brazil, the Philippines and Indonesia. At present, more than 70 product registration applications have been submitted in more than 40 countries, and the company expects some products to gain market access and go public in the second half of the year.

In the first half of 2023, the company actively prepared for albumin paclitaxel EU GMP on-site inspection, has completed technology transfer, steadily promoted the process verification work, and is expected to quickly open the European market after listing.

Introduce R & D talents and promote R & D projects efficiently

In the first half of 2023, six new doctorates were introduced, and the proportion of people with master's degree or above in the R & D team increased to 63.69%. Efficient promotion of clinical projects: polyethylene glycol human granulocyte stimulating factor injection (long-acting GC) phase I clinical successfully completed, the company is actively promoting phase III clinical related work. The Ia phase of human interferon α 1b inhalation solution was successfully completed. Phase I clinical preparation of human growth hormone injection. The phase III clinical trial of SHEN26 capsule has been carried out smoothly and is currently in the process of data cleaning.

Profit forecast: we expect the company's operating income to be 1.388 billion yuan, 1.829 billion yuan and 2.248 billion yuan respectively in 2023-2025; the net profit returned to its mother is-84 million yuan, 18 million yuan and 132 million yuan respectively; and the EPS in 2023-2025 is-0.42,0.09 yuan and 0.66 yuan respectively, and the corresponding PE valuation is-41,192 and 26 times respectively.

Risk factors: the risk of industry policy; the risk that the clinical progress of the project under research is not as expected; the risk that product sales are not as expected; the risk of intensified market competition.

The translation is provided by third-party software.


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