Event: the company recently announced the progress of phase II clinical trials of polyethylene glycol irinotecan (JK1201I) for injection in the treatment of small cell lung cancer. "study on the safety, tolerance and preliminary efficacy of single-dose combined with multiple administration of JK1201I in patients with small cell lung cancer" has recently been approved by the Drug Review Center to conduct phase III clinical trials.
The application value of polyethylene glycol technology has been verified again. Polyethylene glycol irinotecan is a long-acting polymer coupling drug, which can inhibit the activity of Topo-I. The first generation of Topo-I inhibitors approved by FDA in 1994 showed high initial peak concentration, short half-life, high toxicity and low efficacy. Compared with the first generation of Topo-I inhibitors, polyethylene glycol irinotecan can selectively slow release and sustained drug release from leaking blood vessels in tumor tissue. And reduce the division of tumor cells by inhibiting the activity of Topo-I. JK1201I entered the clinical II phase in the fourth quarter of 2021 and was approved to enter the clinical III phase at the present time, which once again proved that JK1201I has ideal effectiveness and safety, so that clinical research can move forward more quickly.
Irinotecan has broad-spectrum anticancer properties, and JK1201I has a large potential long-term market space. Topo-I is overexpressed in many solid tumors, including colorectal, ovarian, breast, glioma, and small and non-small cell lung cancer, so irinotecan can be used to treat a variety of tumors. The first irinotecan liposome Onivyde, which is more significant for the company's variety JK1201I, was approved to treat pancreatic cancer in 2015, with global sales of 127 million euros in 2021.
The company extends smoothly to the lower reaches of the pharmaceutical polyethylene glycol industry chain through irinotecan, and its self-research ability is endorsed. For the domestic pharmaceutical polyethylene glycol leader, in recent years, the company has actively expanded to the lower reaches of the industrial chain, independently developed a number of polyethylene glycol modified drugs and III medical devices and other products, irinotecan as the fastest progress in research and development of the company's self-developed drugs, the rapid promotion of its clinical research for the company's pharmaceutical equipment self-research ability endorsement, the company's polyethylene glycol pharmaceutical application innovation platform prospect.
Maintain a "buy" rating. In the long run, the company is the leading enterprise in the global PEG derivatives industry, mastering the core technology of the whole industry chain of derivative production, has obvious advantages in product quality and customer resources, and is expected to share the market expansion dividend of PEG modification applications. It is estimated that the net profit of homing in 22-24 years will be RMB 332,487 million, maintaining the "buy" rating.
Risk tips: the market competition of new products; the progress of research and development is not as expected; the sales ability of partners is not as expected.