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基石药业-B(02616.HK)公布年度业绩 亏损大幅减少59.3% 将继续推进创新管线药物

Cornerstone Pharmaceutical-B (02616.HK) announced annual results, losses were drastically reduced by 59.3% and will continue to promote innovative pipeline drugs

Gelonghui Finance ·  Mar 27 09:21

On March 27, GLONGHUI | Cornerstone Pharmaceutical-B (02616.HK) announced that for the year ended December 31, 2023, the company's revenue was RMB 463.8 million. The loss during the year decreased from RMB 902.7 million to RMB 535.5 million or 59.3% from RMB 902.7 million in the previous year to RMB 367.2 million, mainly due to a sharp reduction in employee costs and the net profit from the transfer of the avonib business.

The company continues to develop and deepen relationships with major global strategic partners (including partners in China), expand commercialization of marketed and advanced drugs, consolidate the company's early product pipeline of potential pioneers/best-in-class molecules, and obtain more technologies that can enhance the company's R&D capabilities.

The company is also undergoing technology transfer for a variety of imported products, which will help reduce costs and enhance the long-term profitability of the company's products. Specifically, technology transfer applications relating to avatinib are being reviewed by the Drug Evaluation Center. Meanwhile, the technology transfer of platinib (including production and clinical bioequivalence studies) has been successfully completed, and application materials have been submitted to the CDE.

Looking ahead, the company will continue to promote innovative pipeline drugs and maximize the commercial value of mature drugs. Details of anticipated near-term catalysts are set out below. Sugilizumab: In the first half of 2024, the Human Pharmaceutical Products Committee (CHMP) provided advice to the MAA on first-line treatment of phase IV NSCLC in the European Union and obtained MAA approval in the second half of 2024; MAA approval for first-line treatment of phase IV NSCLC in the UK in the second half of 2024; exploration of partnerships outside of China.

Loratinib: Pre-NDA/NDA for the treatment of advanced ROS1-positive NSCLC in mainland China in 2024.

Avatinib: The Original Research Transfer Declaration (ANDA) for localized production is expected to be approved in the second half of 2024.

Platinib: ANDA for localized production is expected to be accepted in the first half of 2024.

Nofazinlimab: Final analysis results of OS 2025 and exploration of partnerships outside of China.

CS5001: Disclosure of the latest clinical safety and efficacy data at international academic conferences (such as ASCO in the first half of 2024 and ESMO/ASH in the second half of 2024); registration studies will be initiated in 2024; global business development (BD) partnerships are expected to be reached in 2024 or 2025.

CS2009: Submit a Clinical Trial Notice (CTN) to the Australian Council on Human Research Ethics (HREC) by the end of 2024, and submit an IND application in China in the first quarter of 2025.

CS5006: The screening of pre-clinical candidate molecules was completed in the first half of 2024, and the IND application is expected to be submitted in 2025; CS5005: The screening of pre-clinical candidate molecules was completed in 2024, and the IND application is expected to be submitted in 2025.

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