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科伦博泰生物-B(06990.HK):ADC征途星辰大海 携手跨国龙头进军国际市场

Columbotai Bio-B (06990.HK): ADC Journey Star Sea joins hands with multinational leaders to enter the international market

國盛證券 ·  Jun 23

Takaya Jianlin took the lead in deploying cutting-edge ADC technology, and the OptiDC platform has obvious advantages. Collumbotai has been deeply involved in ADC innovative molecular research and development for more than ten years. It is one of the first companies in China and one of the few companies in the world to establish an integrated ADC development platform. The OptiDC platform is based on a diverse ADC core component library. It has validated more than ten clinical or pre-clinical drug candidates and enrolled more than 2,000 patients. The OptiDC platform has received more than 40 patents and applications from around the world, forming the company's core technology moat.

Core varieties are leading the way and are about to enter the commercialization stage. At present, the company has declared two ADC candidate products SKB264 (TROP2 ADC) and A166 (HER2 ADC) to the NMPA for listing.

SKB264: Potential first domestically produced TROP2 ADC, which is expected to be approved for sale by the end of 2024. Four indications have been included by the NMPA as a breakthrough treatment. Moderately toxic payload, high DAR, self-developed proprietary Kthiol design linker-payload, and acid-sensitive carbonate structure achieve a balance of safety and efficacy.

A166: The potential second domestically produced HER2 ADC is expected to make a breakthrough in the field of breast cancer and is expected to be approved for marketing within 2024. Site-specific coupling technology, consistent low DAR high cytotoxic Duo-5 payload, stable systemic circulation.

ADC is a global pioneer, and its multiple product potential has been recognized by multinational MNC. The company has successively reached 3 major cooperation licenses with leading multinational pharmaceutical company MSD, with a total transaction amount of nearly 11.8 billion US dollars, making it the first domestic company to export self-developed ADCs to the top ten international MNC. Up to now, MSD has carried out 10 global phase 3 clinical studies of SKB264 (TROP2ADC), covering lung cancer, breast cancer, stomach cancer, cervical cancer, endometrial cancer, etc.; it is expected to form a combination therapy with Keytruda and become a new first-line standard treatment for IO+ADC tumors. As coverage continues to expand, SKB264 is expected to become one of MSD's core assets in the field of oncology.

SKB315 (CLDN18.2 ADC) has also entered the global clinical research phase. International cooperation empowers the company's long-term development and expands the value space for variety innovation.

The overall pipeline gradually became an echelon, entering a harvest period of innovation. According to the official account of Colombotai, the company has established 33 innovative pipelines covering major diseases such as tumors, autoimmunity, inflammation, and metabolism. Among them, marketing applications for anti-PD-L1 monoclonal antibodies and cetuximab antibiotics have been accepted by the NMPA and are expected to be launched within 2024; 14 projects are advancing clinical trials, including multiple global multi-center studies; and 19 pre-clinical assets have laid the foundation for long-term development. The company's innovation team has been formed and is about to enter a new stage of autogenous hematopoiesis.

Profit forecasting and investment ratings. The company's revenue for 2024-2026 is estimated to be 1120 billion yuan, 1,307 billion yuan and 1,966 billion yuan respectively, with year-on-year growth rates of -27.3%, 16.7%, and 50.4%. Summing up the various valuations, the company's reasonable market value is estimated to be about 47.922 billion yuan in 2024. The company has a forward-looking layout in the ADC field, and core products such as SKB264 and A166 are about to enter the harvest period; OptiDC technology platform capabilities have been verified, product pipeline reserves are abundant, the echelon is reasonable, and the prospects for internationalization of leading pharmaceutical companies in cooperation with multinational leading pharmaceutical companies are broad. We are optimistic about the company's long-term development, covered for the first time, and gave it a “buy” rating.

Risk warning: risk of R&D failure, risk of product commercial sales falling short of expectations, risk of international cooperation falling short of expectations, risk of industry growth falling short of expectations.

The translation is provided by third-party software.


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