科伦博泰生物-B(6990.HK):中国ADC执牛耳者 锻造国际化蓝图

Columbotai Bio-B (6990.HK): China's ADC owners forge a blueprint for internationalization

華泰證券 ·  Jun 20

Domestic ADC pioneers joined hands with MNC to cover the international market for the first time, giving it a “buy” rating as the innovative pharmaceutical subsidiary platform of Colon Pharmaceuticals (002422 CH). Since its establishment in 2016, the company has deeply built the three major R&D platforms for large & small molecules and OptiDC ADCs, and 5 of the 14 clinical products have entered the key trial/NDA stage. Based on the company: 1) heavy ADC pipeline (hopefully SKB264 will become the first domestically produced TROP2 ADC); 2) forward-looking layout of immune/tumor targeting macromolecules and using first-line treatment plans with the company's ADC; 3) clinical cooperation with MNC to open up overseas commercialization space (signing cooperation and licensing agreements with MSD, Ellipses, etc. for ADC and other assets), we estimate the company's 24-26 revenue of 14.1/19.6/2.91 billion yuan to achieve break-even in 2026. Under the value method (WACC: 9.4%, sustainable growth rate of 2%), a market capitalization of HK$49.6 billion, corresponding to a target price of HK$222.74, covered for the first time, and gave it a “buy” rating.

SKB264: Cooperate with MSD to advance global multi-centers at full speed, looking forward to significant overseas revenue sharing in 2022. The company signed a licensing cooperation agreement with MSD (MSD) for SKB264/SKB315 and 7 other preclinical ADCs (a total of US$11.8 billion). Among them, the boxing product SKB264/MK-2870 (Trop2 ADC) is the most important ADC asset for MSD, and is expected to obtain impressive overseas shares for Botai: 1) Since 10M23, MSD has centered around MK- 2870 carried out 10 global phase III clinical trials (a total of 8,583 patients are planned), covering NSCLC/endometrial cancer/breast cancer/gastric cancer/cervical cancer, and actively expanding from the back line to the front line; 2) In terms of major breast cancer/NSCLC, MSD conducted 2/5 separate trials. Among them, NSCLC focused on the backline of EGFR mutations and the discovery of early and advanced first-line potential for non-driving gene mutations; 3) Overlapping gastrointestinal tumors and high-incidence gynecological tumors overseas, compared to Dato-DXD Focus on clinical chemistry, optimistic Seize overseas commercialization opportunities.

SKB264: The first domestically produced Trop2 ADC, TNBC 3L+ has significant benefits. On the NSCLC frontline domestic side, the SKB264 is estimated to be marketed on 2H24 with TNBC 3L+ as the first indication. We are optimistic that this variety will hit a total domestic sales peak of 6.7 billion yuan in 2030. The main reasons: 1) domestic companies have developed 15 indications, focusing on breast cancer and lung cancer; 2) 2024 ASCO TNBC (3L+) phase III data is impressive, with 5.7 MPFS/ORRs under a single drug, respectively. Month/ 43.8% (compared to 2.3 months/ 12.8% of chemotherapy), the benefits are significant across the ages; 3) 2024 ASCO combined with A167 against EGFR wild NSCLC (1L) phase II, 1A cohort ORR/ mPFS reached 48.6% /15.4 months, and 1B cohort ORR was as high as 77.6%, establishing its important position in first-line treatment of this indication.

Differentiated oncology/immunological clinical layout, ADC/small and large molecule platforms are expected to achieve sales of more than 4 billion yuan in 2030, covering a significant amount of: 1) A166 (HER2 ADC) is expected to be listed with HER2+ BC (3L+) in 24, and we are optimistic about its potential for subsequent second-line expansion; 2) A167 (PD-L1): nasopharyngeal cancer (3L+) indications are expected to be approved conditionally on 1H24; 3) A140 (EGFR monoclonal antibody): RAS is likely to be indicated for wild colorectal cancer 2H24 approved for marketing; 4) A400 (RET) RET+NSCLC entered critical clinical phase II.

Risk warning: Experimental data for key varieties falls short of expectations, clinical progress falls short of expectations, commercialization risks.

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