The company revealed that the interim data of its core product CS1001 (PD-L1 monoclonal antibody) for the treatment of first-line squamous and non-squamous non-small cell lung cancer has reached the main clinical end point targeting PFS.
Pralsetinib and avapritinib, the cooperation lines between the company and Blueprint, have also made a number of clinical and listing approval progress in major markets.
We believe that Cornerstone Pharmaceutical is still undervalued in the biopharmaceutical sector. Maintain the buy rating and keep the target price of HK $19.83 based on rNPV valuation unchanged
CS1001 may submit a new drug listing application in the fourth quarter of 2020
The company's CS1001-302 is a separate clinical design from other competitors and is a combined low-cost phase III clinical trial (nearly 500patients) that includes both squamous and non-squamous non-small cell lung cancer subtypes. The company says the clinical design will help shorten the duration of clinical trials and reduce the number of patients enrolled and the need for funding. The interim data showed that CS1001 combined with chemotherapy could improve the median progression-free survival (mPFS,7.8 vs. 4.9 months, HR 0.5), and the safety data were consistent with the previous data. We believe that the mid-term data of CS1001-302 are comparable in similar indications of competitive products. The company will release full data at a future academic conference and plans to submit its new drug listing application to the SFDA in the fourth quarter. We believe that this data reflects the company's strong clinical research and development capability, and the cost-effective clinical progress of large indications will increase the revaluation space of the company's valuation and shorten the valuation gap with comparable companies.
Cooperative development projects have also made positive progress.
The company announced that its cooperative pipeline pralsetinib (RETi) has also achieved positive efficacy and safety data in the Chinese population in the field of RET+ non-small cell lung cancer treatment. At the same time, partner Blueprint has submitted two additional listing applications for pralsetinib to FDA, namely advanced or metastatic RET+ medullary thyroid carcinoma (MTC) and RET+ thyroid cancer. We believe that a number of positive developments in pralsetinib and the acceptance of avapritinib's application for new drugs will further enhance the company's strength in the field of innovative oncology drugs.
The stock price has rebounded recently, but the overall stock price performance still lags behind.
The company expects to receive a new drug marketing approval (ivosidenib) this year and complete five applications for different indications from three core pipelines, PD-L1, avapritinib and pralsetinib. The company is moving from a clinical biotechnology company to a biotechnology company with a number of commercial products. In view of the company's clinical progress, we believe that the company deserves to be revalued by the market to shorten the valuation gap with comparable companies. We maintain our buy rating with a target price of HK $19.83. We are optimistic about the company's rich R & D pipeline, excellent clinical team and Becton Dickinson & Co ability.
