A leader in dual antibody technology, focusing on the development of innovative cancer treatments. The company has created the world's leading Fc-based heterodimeric bispecific antibody research and development platform, effectively solving the chemical, production and control problems of bispecific antibody development. Based on its own platform technology, the company focused deeply on innovative cancer therapy research and successfully developed a number of potential best-in-class products such as KN035, KN026, KN046, JSKN003, etc. Among them, KN035 (PD-L1 monoclonal antibody) was successfully approved for listing in 2021, and a number of indications in the late clinical stages of KN026,, and. KN046 JSKN003
KN035: The world's first approved subcutaneous PD- (L) 1 antibody for subcutaneous injection, with a differentiated competitive advantage.
Approved for listing in China in 2021, it is suitable for the treatment of patients with advanced solid tumors in adults with highly unstable non-resectable or metastatic microsatellites (MSI-H) or mismatched repair gene defects (dMMR).
Envolizumab has advantages over similar drugs in terms of efficacy, safety, convenience, and compliance. Currently, it has been included in the CSCO six major cancer diagnosis and treatment guidelines, and sales continue to be released.
KN026: HER2 double antibody, excellent curative effect for HER2 positive gastric cancer/breast cancer. The efficacy of KN026 monotherapy for HER2-positive gastric and gastroesophageal carcinoma conjugated adenocarcinoma is not inferior to the HER2 ADC drug DS-8201, and registered clinical trials for patients with HER2-positive gastric cancer (including gastroesophageal adenocarcinoma) with chemotherapy 2L are ongoing. At the same time, compared to non-head-to-head PHT (trastuzul+pertuzum+docetaxel) triple therapy, KN026 combined with albumin docetaxel 2L for HER2+ breast cancer is superior in terms of median progression-free survival (MPFs) and 24-month OS rate, and is currently undergoing head-to-head registration clinical trials with PHT therapy.
JSKN003: HER2-ADC, significantly superior in security to competitors, has BIC potential. JSKN003 is an antibody-coupling drug independently developed by the company using a unique sugar fixed-point coupling platform. Phase I clinical data carried out in Australia showed that the safety was significantly superior to competing products such as DS-8201 and the curative effect was not poor, and it had good prospects for becoming a drug. In October 2023, the company initiated a phase III clinical trial for breast cancer indications with low HER2 expression.
KN046: PD-L1/CTLA-4 bispecific antibody, is expected to be the best treatment for 1L pancreatic cancer indications. KN046 has conducted nearly 20 clinical trials at various stages covering more than 10 types of tumors, including non-small cell lung cancer, pancreatic cancer, thymus cancer, liver cancer, esophageal squamous cell carcinoma, and tri-negative breast cancer in Australia, the US and China. Among them, KN046 combined with albumin paclitaxel and gemcitabine has outstanding efficacy in 1L pancreatic duct cancer indications. Phase II clinical MoS data have been around 12 months, and phase III clinical trials are ongoing. Once clinical trials are successful, KN046 is expected to become the best drug in its class for 1L treatment of pancreatic cancer. In terms of indications for non-small cell lung cancer, the mid-term analysis of KN046 combined chemotherapy with 1L of chemotherapy for NSCLC has successfully reached the pre-set PFS endpoint. The data for the treatment of NSCLC phase II with KN046 combined with axitinib 1L is excellent, and the commercialization prospects are worth looking forward to.
Profit forecast and investment recommendations: We expect the company's operating income for 2023-2025 to be $330 million, $4.7 billion and $1.37 billion respectively, up 97%, 43%, and 191% year on year; net profit is -290 million yuan, -220 million yuan and 130 million yuan, up 11%, 25% and 158% year on year. As a leading domestic bi-antibody technology enterprise, the company focuses on innovative tumor therapy development. The antibody technology platform capabilities have been commercially tested, and the differentiated pipeline layout is gradually entering the harvest period. We are optimistic about the company's future long-term development, covering it for the first time, and giving it a “buy” rating.
Risk warning: core pipeline clinical progress falls short of expectations, increased market competition, loss of core R&D managers, poor quality control of product production, etc.