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迪哲医药(688192):具备全球竞争力的创新型BIOTECH

Digger Pharmaceuticals (688192): Innovative BIOTECH with global competitiveness

華泰證券 ·  Dec 5, 2022 00:00  · Researches

Dizhe Medicine: source Innovation, based in China, aiming at the whole World

Dizhe Pharmaceutical insists on source innovation and relies on top R & D teams and its own technology platform to develop products with real clinical needs and global competitiveness. A number of products (Shuvotini and Golixitinib) have been agreed by China and the United States to speed up the review and launch with phase 2 key clinical results. The company focuses on the distribution of oncology, autoimmunity, metabolism and other fields, pipelines are carried out in China and the United States at the same time to lay the foundation for the follow-up sea. At present, a total of 5 products are in the clinical stage, and the company expects the first product to be approved for listing in 23 years, and the pipeline will usher in the harvest period. We expect the company to continue to lose money in 22-24 years (return to the mother's net profit-7.2max / 72max / 490 million). Using the DCF method, we give Dizhe a target market capitalization of 21.21 billion yuan, corresponding to a target price of 52.48 yuan, with a "buy" rating for the first time.

Suvotinib (DZD9008): global best in class (BIC) product, the core product of the company with great potential to go to sea, suvotinib is an oral EGFR-TKI for the treatment of Exon 20ins non-small cell lung cancer. It is expected to be approved to market in China / the United States in 24 years, 2L treatment ORR will reach 59.8% (vs is the only similar product approved in the world ORR 28%), and has 1L treatment development potential. We expect the product to reach a sales peak of 2.51 trillion yuan in China / overseas, respectively, with a corresponding product valuation of 46.7 / 12.11 billion yuan. Against the US Turning point Healthcare (6M22 was acquired by BMS for $4.1 billion, its core asset ALK/ROS1/NTRK small molecule inhibitor Repotrectinib is the ROS1+ NSCLC field BIC drug, and 1L treatment ORR 79% vs has been approved for less than 70%), we believe that sulvotinib is expected to go out to sea with a total transaction consideration of about $1.5 billion, boosting the company's valuation.

Clinical pipeline with innovation and differentiation

In addition to sulvotinib, the company has four other pipeline products in the clinical stage: 1) DZD4205: highly selective JAK1 inhibitor (registration phase 2), we expect (the same below) the first indication, r PTCL, is expected to be approved for market in China and the United States in 24 years; 2) DZD8586: hematoma, has entered phase 1 clinical; 3) DZD1516:HER2 small molecule, with blood-brain barrier penetration, international multicenter phase 1 clinical completion 4) DZD2269:A2aR antagonist, phase 1 international multicenter clinical trial. In addition, there are several early-stage small molecule targeting drugs in the pipeline to supplement the R & D pipeline.

Creative R & D management team, high-level transformation science platform company's core competence has covered the whole industry chain from early discovery of new drugs to late commercialization, thanks to: 1) R & D management team with a global vision: founder Dr. Zhang Xiaolin and most of the core R & D personnel are former members of AstraZeneca PLC Asia R & D Center team. He has led the development and commercialization of many star projects of AstraZeneca PLC (founder Dr. Zhang Xiaolin has led or participated in the research and development of Iressa, Teresa, etc.), and has accumulated rich experience in the research and development of small molecule innovative drugs. 2) Integrated R & D platform: the company has industry-leading transformation science capability and technology platform, aggregating bioscience, pharmaceutical chemistry, pharmaceutical ADME and other disciplines to provide support for new drug R & D projects.

Risk hint: the risk of failure in new drug research and development and the risk of uncertainty in product commercialization.

The translation is provided by third-party software.


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