Nellick, the first third-generation BCR-ABL inhibitor, has a good initial sales performance, and the sales prospect is promising: the company's core product, HQP1351, will be launched in China at the end of November 2021, and is the first third-generation BCR-ABL inhibitor in China to treat adult patients with chronic myeloid leukemia (CML) with T315I mutation in chronic phase (CP) or accelerated phase (AP). By the end of February 2022, HQP1351 sales reached 50.41 million yuan. The company actively arranges commercial channels, has established strategic cooperation with supply chain service providers represented by Sinopharm Group, Shanghai Pharmaceutical Holdings and China Resources Pharmaceutical, and has entered Huimin Insurance in 10 cities. Relying on the joint commercial promotion team of the company and INNOVENT BIO, the company has covered 80% of the national CML market. We are optimistic about Nellick's sales in 2022.
APG-2575 has successfully entered the registered clinical stage, and the second commercial Bcl-2 inhibitor is expected in the world. APG-2575 is the second Bcl-2 selective inhibitor in the world to enter the registered clinical research stage. The key registered phase II clinical study for the treatment of R CLL/SLL was approved by CDE at the end of 2021 and the first patient administration was completed in March 2022. According to the global phase I clinical study data presented at the annual meeting of 2021ASCO, APG-2575 showed 80% ORR and good safety in R CLL/SLL patients in 15 assessable patients, and no tumor lysis syndrome was observed even if the dose was increased daily. According to the Chinese phase I clinical data presented at the annual meeting of ASH, all 6 CLL subjects treated with 200mg and above dose of APG-2575 benefited, with an ORR of 100%, including 1 case of CR and 5 cases of PR. In addition, IND for the treatment of advanced ER+ breast cancer or other solid tumors with APG-2575 alone or in combination is approved by FDA. Up to now, APG-2575 has carried out 18 clinical studies involving different indications of hematological tumors and solid tumors worldwide, showing great potential for clinical development.
Becton Dickinson & Co has made progress in many dimensions, such as commercialization, foreign authorization and cooperative development: the company is constantly looking for cooperation opportunities. In terms of commercial cooperation, the cooperation with INNOVENT BIO will continue to contribute to the commercial promotion of HQP1351 in China.
In terms of product licensing, the company authorized partner UNITY Biotechnology's anti-aging drug UBX1325 clinical development is advancing rapidly, its phase I clinical trial in the treatment of advanced vascular ophthalmopathy patients has obtained positive data, and has completed the first patient administration of the follow-up phase IIa clinical trial, the company received a milestone payment of US $2 million. In addition, the company has actively started the pace of preclinical and clinical development cooperation, and reached a number of clinical cooperation with international academic institutions and multinational enterprises, such as NCI, Pfizer Inc, Clover Biology and so on. A series of cooperation not only validates the company's long-standing excellent product R & D capability, but also lays a solid foundation for future overseas R & D and sales.
Our point of view: the listing of HQP1351 marks the formal commercialization of the company, and the initial sales are gratifying. The company's core product HQP1351 has a significant differentiation advantage, fully approved registration clinical research is under way, and has the potential of best-in-class. APG-2575 products can be combined with a wide range of drugs, and have the potential to become "PD-1 monoclonal antibodies" in the treatment of hematological tumors. Joint development with multinational pharmaceutical companies is expected to release the global potential of products.
At present, the company has 9 products under development, 2 in the registered clinical stage, and the follow-up products continue to be strong. It is recommended to pay attention.
Risk tips: research and development progress is not as expected, market competition intensifies, policy risks and so on.