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基石药业-B(02616.HK):迈向管线2.0 ROR1ADC潜力十足

Cornerstone Pharmaceutical-B (02616.HK): Towards pipeline 2.0 ROR1ADC has full potential

Tianfeng ·  Mar 10

Summary:

Cornerstone Pharmaceutical is an innovation-driven biomedical enterprise focusing on anti-tumor drug research and development. As of February 2025, the company has successfully marketed 4 innovative drugs, approved 16 new drug marketing applications (NDAs), and 9 indications. The current R&D pipeline is balanced with 16 drug candidates, including potentially first-in-class or best-in-class antibody-conjugated drugs (ADCs), multi-specific antibodies, and immunotherapy and precision therapy drugs.

The company's main commercial products, sugarimab (PD-L1), platinib (RET), and avatinib (KIT/PDGFRA), have been commercialized; the key clinical projects CS5001 and CS2009 in the R&D pipeline 2.0 have great potential and are expected to continue to drive business growth.

Pipeline 2.0: restart and give full play to the company's R&D advantages

CS5001 (ROR1 ADC): CS5001 is a seed player in the company's current 2.0 pipeline. It has shown good potential benefits in multiple hematoma indications, and has also shown good tumor inhibitory activity in the field of solid tumors. Furthermore, the ROR1 ADC zilovertamab vedotin, a competitor with the same target and mechanism, has shown impressive data (100% CR) in 1L DLBCL. We believe that the company's CS5001 is expected to reap good commercialization results with its differentiated design and the second-highest clinical progress in the world.

CS2009 (PD-1/VEGF/CTLA-4 triple antibody): Preclinical data showed that crosslinking with VEGFA can significantly enhance anti-PD-1 and anti-CTLA4 activity, and has clearly superior anti-tumor activity to potential competitors. On December 23, 2024, Cornerstone Pharmaceuticals announced that CS2009 had submitted a clinical trial application in Australia. Considering the potential shown by PD-1, VEGF, and CTLA-4 targets in single drugs and in combination, the good pre-clinical data of CS2009 and the scope of application of common tumors, CS2009 is expected to become the next promising variety after CS5001.

Pipeline 1.0: Many potential varieties have entered the commercialization stage, and local production is expected to accelerate the implementation of results

Sugarimab: It is the 2nd PD-L1 monoclonal antibody produced in China and the 4th PD-L1 monoclonal antibody approved domestically. As of February 2025, all five indications of sugarizumab have been approved in mainland China, and domestic commercialization has been authorized to Pfizer, so Cornerstone Pharmaceuticals can receive license revenue. In 2024, sugarizumab 1L NSCLC indications were successively approved in the European Union and the United Kingdom. Subsequent revenue and milestones from overseas partners are expected to continue to increase the company's revenue.

Platinib & Avatinib: Both drugs were introduced from Blueprint in 2018. The drug competition pattern is good, and the cost is high because local production has not been completed. Considering that the commercialization of Platinib and Avatinib is currently authorized to Alis and Hengrui Pharmaceuticals, and after local production is completed, the company is expected to improve drug accessibility through strategies such as price reduction and medical insurance. The next 2 products are expected to accelerate the release of the next 2 products.

Profit forecast

We expect the company's total revenue for 2024-2026 to be 0.386/0.516/0.829 billion yuan, with year-on-year increases of -16.68%/33.59%/60.62%, respectively; net profit attributable to shareholders of listed companies is -0.003/0.029/0.093 billion yuan, respectively.

The company has entered the pipeline 2.0 era. Considering the outstanding commercialization potential of ROR1 ADC and PD-1/VEGF/CTLA-4 and the accelerated commercialization of existing varieties, the market value of the company is estimated using the DCF method. Assuming that WACC is 7.29%, the sustainable growth rate is 0.5%, the corresponding market value is 8.673 billion HKD/share, and the target price is HK$6.75 per share.

Risk warning: drug development risk, market competition risk, operating risk, Hong Kong stock liquidity risk, estimation is subjective risk

The translation is provided by third-party software.


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