科伦博泰生物-B(6990.HK):首款TROP2ADC获批在即 携手国际巨头打造新一代ADC龙头

Columbotai Bio-B (6990.HK): The first TROP2ADC was approved and will soon join hands with international giants to build a next-generation ADC leader

華西證券 ·  May 16

As a leading manufacturer of next-generation innovative drug ADC products, the company has many leading tumor products with many years of industry experience and advanced platform technology. Among them, SKB264 (the first self-developed Trop2 ADC) and A166 (HER2 ADC) are about to be approved, and it is expected that they will be solved as soon as possible to meet the clinical needs of patients. There are also important core assets such as SKB315 (Claudin18.2 ADC), A167 (PD-L1 monoclonal antibody), A140 (the first cetuximab antibiotic analog), and A400 (second-generation RET small molecule inhibitor), which are expected to fully blossom in the multi-indication field. In 2022, the company reached 3 important deals on core ADC assets with international pharmaceutical company MSD, with a total amount of US$11.8 billion. As of April 2024, the company has confirmed receipt of down payments+partial milestone payments totaling US$280 million, and the company has sufficient cash reserves. The international clinical process of SKB264 has accelerated. Up to now, MSD has intensively launched 8 global Phase III projects. According to the company's 2023 annual results announcement, SKB264 has achieved a number of key developments at home and abroad: 1. A total of 4 breakthrough therapy qualifications have been granted by CDE; 2. 2L+ treatment of TNBC has reached the end and an NDA application has been officially submitted (priority review); 3. Single-drug treatment with EGFR mutation NSCLC key phase 3 completed the enrollment of the first patient; 4. Domestic PD-L1 monoclonal antibody A167 (with or without chemotherapy) is actively progressing in phase 2 clinical trials for EGFR wild NSCLC; 5 . Domestic single drug treatment 2L+ HR+/HER2-BC key phase 3 clinical trial was initiated; 6. Domestic clinical approval for HR+/HER2-BC treatment with or without A167 (PD-L1) 1L was approved. 7. Overseas in 2023, MSD launched a total of three clinical trials, respectively: single drug treatment for 3L EGFRM NSCLC, single drug treatment for 3L endometrial cancer (EC), and combined K drug treatment for 1L PD-L1 > 50% NSCLC.

With years of experience in the industry, the first domestically produced Trop2 ADC is a biomedical company focusing on R&D, manufacturing and commercialization of innovative drugs. Since its establishment in 2016, it has always been committed to solving the medical needs of China and the world. As a pioneer and one of the leading developers of antibody drug conjugates (ADCs), Columbotai owns OptiDC, the first batch of integrated ADC R&D platforms in China. Among them, the two main antibody-drug conjugate drugs developed - SKB264 and A166 - are core products developed independently by the company. As the first Trop2 ADC self-developed product to be launched, SKB264 has been included as a breakthrough treatment by the China National Drug Administration (NMPA), targeting triple-negative breast cancer, EGFR mutant non-small cell lung cancer, HR positive/HER2 negative breast cancer, and first-line advanced PD-L1 negative TNBC. As a third-generation HER2 targeted ADC product, A166 is expected to become the first single product approved for use in breast cancer in China.

MSD authorized MSD overseas for a number of ADC products worth 11.8 billion US dollars, verifying the hard power of independent research and development. Over the years, the company has actively cooperated to achieve a win-win situation. Throughout 2022, the company and multinational giant MSD successfully reached three major licensing agreements, with a total licensing amount of nearly US$11.8 billion, ranking first in the world in licensing transaction cooperation in the global pharmaceutical industry in 2022, and international cooperation to verify R&D strength. Currently, SKB264, an important global phase III clinical product, is progressing at an accelerated pace; SKB315 is a Claudin18.2ADC that targets Claudin 18.2 and has been proven to have high proliferative inhibitory effects in multiple tumor lines; SKB410 mainly targets Nectin-4 and several pre-clinical ADC projects are being actively explored in phase I. Strong international cooperation is expected to enable enterprises to start a new era of innovative research and development.

Investment advice

The company's independent research and development capabilities are strong, the technical platform advantages are obvious, the management team is experienced, and the clinical indication pipeline is progressing steadily. Judging from Sullivan's global cancer incidence trends and the relevant competitive pattern shown by current clinical data, sales of the company's core products are expected to grow steadily. The layout at home and abroad is reasonable. Considering the overseas licensing share and the pace of product listing, considering the overseas licensing share and the pace of product listing, we predict that in 2024-2026 the total operating revenue of the company will be 13.02/18.95/2,389 billion yuan, up -15.5%/45.6%/26.1% year-on-year respectively, and net profit to mother of -5.6/-8.1 billion yuan, up 1.7%/-42.9%/154.1% year-on-year respectively. The corresponding earnings per share are -2.57/3.68/1.99, respectively yuan. I am optimistic about the company's commercial operation capability after product launch, the continuous release of products, and the continuous introduction of new innovative target pipelines. Using the free cash flow DCF discount valuation method, the company's valuation is 48.300 billion yuan, corresponding to the stock price of 230.2 yuan. Assuming that the exchange rate of RMB to Hong Kong dollar is 1.08, equivalent to HK$248.6, the first coverage gives the company a “buy” rating.

Risk warning

R&D falls short of expectations, market competition intensifies, technology upgrades and product iteration risks; commercialization falls short of expectations, causing drug sales to fall short of expectations; overseas promotion falls short of expectations.

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