Nano drug delivery system DSS gives paclitaxel products “new vitality”

Paclitaxel is currently the most widely used broad-spectrum cancer chemotherapy drug. The company's core product, paclitaxel micellar for injection, innovates dosage forms based on traditional paclitaxel. Exclusive pharmaceutical excipients are screened through unique polymer synthesis technology, and paclitaxel dosage forms are synthesized using nanotechnology to greatly improve product safety and efficacy. Paclitaxel micelles obtained 390 mg/m2 MTD and 435 mg/m2 of DLT in phase I clinical trials, which is the highest dose currently achievable by paclitaxel preparations. In June 2022, injectable paclitaxel polymer micelles were included in the “Chinese Medical Association Lung Cancer Clinical Diagnosis and Treatment Guidelines (2022 Edition)”. After being included in the guidelines, the influence of the product was further strengthened, achieving revenue of 235.96 million yuan for the full year of 2022. The fastest development progress of similar competitive products is in phase II clinical, and the company will still maintain the first-mover advantage of exclusive sales for 3-5 years.

Sales and production capacity are advancing simultaneously, and commercialization of products is beginning to bear fruit. The company's domestic sales model is mainly self-operated. Some regions have commissioned Baiyang Pharmaceutical sales as a supplement to speed up the marketization process of paclitaxel products. In 2022, the company's sales force was expanded to 120 people, and the hospital terminal sales map was laid out to further strengthen terminal coverage. Currently, the company is in the dual promotion stage of DTP pharmacy and hospital side store sales+hospital admissions, and sales in some regions are expected to enter a sales period when the number of admissions increases. By the end of 2022, the company added an annual production capacity of 1 million units, and is expected to be commercialized officially in mid-2023. In 2023, the company raised capital for “Annual output of 5 million paclitaxel polymer micelles for injection and construction of supporting facilities”, with a view to rapidly increasing production capacity to meet future market sales demand for injectable paclitaxel polymer micelles. The company's penetration rate in 2022 was about 0.66%. Considering the expansion of the company's sales force and the base of 24 clinical hospitals, the company is expected to achieve 1.55%, 2.29%, and 3.7% in 2023-2025.

Steadily advancing research pipelines

Actively promoting the expansion of paclitaxel micellar indications. Breast cancer has now been approved by the CFDA for phase III clinical trials. It is expected that phase III clinical trials will be completed in 2024-2025, further advancing the product commercialization process. Breast cancer is the disease with the highest incidence rate in the world, and after approval of this indication, paclitaxel micellar sales are expected to reach new heights. The company also promotes research and development of two types of targeted nano-paclitaxel polymer micelles, namely targeted polypeptide-coupled nano-micelles for the treatment of pancreatic tumors and targeted small-molecule conjugated nano-micelles drugs for the treatment of prostate tumors and pancreatic tumors. By modifying targeted peptides/small molecules on the surface of paclitaxel nanomicelles, they form an actively targeted nanopharmaceutical delivery system to increase drug concentration in tumor tissue. Leveraging the advantages of polymer excipients synthesis and nano-drug delivery system R&D platforms, the company has developed two types of targeted nano-micellar drugs for solid tumors: docetaxel micelles and cabataxel micelles, all of which are currently in the pre-clinical research stage.

Profit forecasting

It is predicted that the company's revenue for 2023-2025 will be 588, 11.14, and 1,360 million yuan respectively, net profit of 307, 581 and 702 million yuan respectively, and EPS of 2.13, 4.04, and 4.88 yuan respectively. The current stock price corresponding to PE is 45.1, 23.8, and 19.7 times respectively, giving a “buy” investment rating.

Risk warning

Risks such as increased competition, falling short of expectations in sales, and reliance on a single product.