\u3000\u3 Guocheng Mining Co.Ltd(000688) 266 Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) )
Performance summary: the company’s revenue in 2021 was 190 million yuan (+ 588.2%), realizing a net profit of – 450 million yuan and deducting a non net profit of – 500 million yuan. In the first quarter of 2022, the company’s revenue was 40 million yuan, and the net profit was – 120 million yuan, deducting non net profit of – 130 million yuan.
Donafenib was approved to be listed in June and achieved an income of 160 million yuan during the year. It is worth looking forward to its large volume in the future. The first indication first-line treatment for hepatocellular carcinoma of the company’s heavy variety donafenib was approved for listing in June 2021, with a sales revenue of 160 million yuan during the year. Donafenib has been included in the national medical insurance catalogue in 2021, and has been included in many clinical guidelines of the health commission and CSCO, which will help the drug to be widely popularized in clinic. The follow-up indications of donafenib are also progressing smoothly: 1. The indications of locally advanced / metastatic radioiodine refractory differentiated thyroid cancer have been submitted to NDA; 2. It is expected that fel-1 and naldenafil-1 will be used in three clinical stages of long-term anti-PD treatment, respectively.
Jaketinib has excellent clinical data and is expected to become a potential drug of mebetter. The phase II clinical trial data of JAK inhibitor jakotinib for the treatment of medium and high-risk bone marrow fibrosis show that its effective rate is significantly higher than the historical data of similar drugs lucotinib, which is expected to become a mebetter innovative drug with the same mechanism. The global sales of lucotinib exceed US $3 billion, and jakotinib has considerable potential. Research and development progress of jacktinib: the treatment of medium and high-risk bone marrow fibrosis is in phase III clinical, and the bone marrow fibrosis intolerant to lucotinib is in phase IIB clinical; The treatment of severe alopecia areata is in phase III clinical practice, which is the first echelon drug in China for the treatment of alopecia areata; Moderate and severe atopic dermatitis, idiopathic pulmonary fibrosis, ankylosing spondylitis, moderate and severe plaque psoriasis and graft-versus-host disease are in phase II clinical stage; The indications of cream in the treatment of mild to moderate alopecia areata (external use) and mild to moderate atopic dermatitis (external use) are in phase I / II clinical practice. The treatment of bone marrow fibrosis has obtained the qualification of FDA orphan drug, and the phase I clinical trial in the United States has been started. The product is worth looking forward to going to sea.
The competition pattern of recombinant human thrombin for external use is good, and it is worth looking forward to its listing. Recombinant human thrombin for external use of biological hemostatic drugs is the primary endpoint of phase III clinical results. The company has completed the pre BLA communication application. The drug is the only recombinant human thrombin in the experimental stage in China. The competition pattern is good. The clinical data show that the hemostatic effect is good, and it has the potential to be widely used in surgical hemostasis. According to Frost & Sullivan’s prediction, the market scale of surgical local hemostasis in China is about 8 billion yuan, and recombinant human thrombin is expected to gain a considerable market share after it is listed.
Continue to increase R & D investment and enrich the pipeline under research. The company continued to increase R & D investment. In 2021, the R & D investment was 510 million yuan, an increase of 62.1% year-on-year. A total of 16 companies are mainly developing new drugs, covering the fields of tumor, bleeding and blood diseases, hepatobiliary diseases, immune inflammatory diseases and so on. Early projects include several dual antibodies, one triple antibody, KRAS inhibitors and other innovative drugs with scarcity.
Profit forecast and investment suggestions. It is estimated that the EPS from 2022 to 2024 will be -0.88 yuan, -0.38 yuan and 0.1 yuan respectively. Considering the rapid and large-scale listing of donafenib, many subsequent varieties / new indications are in the late clinical stage and are expected to be approved for listing in recent three years. The company’s performance is supported and maintains the “hold” rating.
Risk warning: the R & D Progress of the project under research is less than expected; Sales promotion ability has not been verified.
