According to a research report released by Tianfeng Securities, it covered Colombotai Bio-B (06990) for the first time, with an “increase in holdings” rating. The company's revenue for 2024-2026 is estimated to be 1.217 billion yuan, 1.654 billion yuan, and 2,476 billion yuan, respectively; net profit to mother is -0.72 billion yuan, -0.606 billion yuan, and -0.415 billion yuan, respectively. Considering the outstanding advantages of the company's ADC technology platform, the core products have large market space, and good prospects for going overseas, I am optimistic about the company's development.

Tianfeng Securities's main views are as follows:

ADC's self-development capabilities are outstanding. Global R&D is being promoted by MSD, and commercialization certainty is strengthened

Kolumbotai's ADC R&D platform OptiDC has independent intellectual property rights, and has a full-process development system from R&D to production. As of June 2024, the company has a total of 5 ADCs in clinical development. Among them, A166 (HER2-ADC) and SKB264 (TROP2-ADC) have entered the NDA stage, SKB315 (Claudin18.2-ADC), SKB410 (Nectin-4), and SKB518 (PTK7) are in clinical phase I, and many products are in the preclinical research stage. The company's ADC R&D capabilities are well recognized by international giant MSD, and a number of collaborations have been reached on SKB264 and other products under development, totaling about 11.8 billion US dollars.

The TROP2ADC market has broad prospects. SKB264 and Keytruda have carried out a number of phase III clinical trials, and have officially entered the commercialization stage. TROP2 is highly expressed in high-incidence tumors such as breast cancer, lung cancer, and stomach cancer. Globally, only two TroP2ADC models, were approved for the market, Skb264 by Columbago and Trodelvy by Gillette. The SKB264 is the most advanced TROP2ADC made in China and the top three in the world. It also has Gilead's Trodelvy and Daiichi Sankyo's DS-1062 in the first tier. MSD has launched a total of 10 global phase III clinical trials around the company's core product SKB264 (MK-2870), covering various tumors such as non-small cell lung cancer, endometrial cancer, breast cancer, and gastric cancer.

Recently, SKB264 (lukansastuzumab) has been approved for marketing in China and has officially entered the commercialization stage. SKB264 also has multiple indications such as non-small cell lung cancer and breast cancer in China. Among them, 4 indications of 1L advanced PD-L1 negative TNBC, 2L or more locally advanced or metastatic TNBC, EGFR positive NSCLC after EGFR-TKI treatment failure, and HR+/HER2-breast cancer were identified by CDE as breakthrough treatments. Among them, NDA applications for locally advanced or metastatic TNBC and NSCLC have recently been approved for marketing.

SKB264 has excellent curative effects and good prospects for going overseas

SKB264 has obtained excellent clinical efficacy data for backline TNBC, 1LTNBC, and NSCLC indications for posterior EGFR mutations. It showed higher efficacy than Trodelvy and DS-1062 (non-head-to-head) in TNBC indications after monotherapy. Furthermore, the test data of SKB264 in the treatment of 1LTNBC mutation with PD-L1 was also superior to the combined data of DS-1062+PD-L1 (non-head-to-head); its performance in NSCLC with EGFR mutations after treatment was ahead of Trodelvy, DS-1062, and Cinda's three-drug therapy (non-head-to-head). MSD has initiated global phase III clinical trials with 10 indications, including 1LNSCLC squamous cell carcinoma classification (combined K drug) and 2L+ gene mutation NSCLC, with good prospects for overseas commercialization. MSD's mature sales network and commercialization capabilities are expected to maximize the commercial value of SKB264.

A variety of products are about to enter the commercialization stage, and subsequent pipelines will form an echelon

The company currently has NDA applications for four drugs accepted by CDE, namely A167 (PD-L1 monoclonal antibody) and A166 (HER2)

ADC), A140 (cetuximab biosimilar), and SKB264 (TROP2ADC). Follow-up pipelines have been formed, and pipelines such as A223 (JAK1/2 inhibitor) and A400 (RET inhibitor) have entered phase II clinical trials; pipelines such as SKB410 (NectIn4ADC), SKB378 (TSLP monoclonal antibody), and SKB518 (PTK7) are in phase I clinical trials.

Risk warning: risk of failure in R&D of innovative varieties; risk of profit falling short of expectations; policy and regulatory risk; measurement of subjective risk.