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3D MEDICINES(01244.HK)公布年度业绩 研发开支增加21.3% 前瞻性布局多肽肿瘤疫苗和mRNA肿瘤疫苗

3D MEDICINES (01244.HK) Announces Annual Results R&D Expenses Increased by 21.3% Forward-looking Layouts for Peptide Oncology Vaccines and mRNA Oncology Vaccines

Gelonghui Finance ·  Mar 28 00:43

Gelonghui announced on March 28 | 3D MEDICINES (01244.HK) that in 2023, all of the company's revenue will come from the sale of commercialized Enveda (Envolimab, subcutaneous PD-L1) to pharmacy operators and distributors directly cooperating with the company. For the year ended December 31, 2023, the company's revenue increased 11.9% from RMB 567.4 million in the same period in 2022 to RMB 634.9 million, reflecting the rapid growth in sales since Enveda went public in 2021. Thanks to the diversified advantages of products, strategic cooperation with mature sales platforms before launch, and an efficient sales team, the company's Enveda has achieved good sales performance in fierce market competition. The company's gross profit increased 11.6% from RMB 525.2 million in the previous year to RMB 585.9 million, mainly due to increased product sales.

For the year ended 31 December 2023, the company's R&D expenditure increased by 21.3% from RMB 350.9 million in the same period in 2022 to RMB 425.5 million. The increase was mainly due to (i) an increase of RMB 52.1 million in third-party contract fees paid to service providers; (ii) an increase of RMB 56.5 million in employee benefit expenses relating to R&D personnel (including salaries, social insurance, pensions, bonuses and share-based expenses); and (iii) a reduction of RMB 34.6 million in advance fees and milestone costs associated with authorizing the introduction of exclusive development rights for drug candidates in designated regions.

For the year ended December 31, 2023, the company has made significant progress in advancing the product line under development, including 12 drug candidates. Among them, Envida (envolimab, subcutaneous PD-L1 injection) has been successfully commercialized. Among them, lung cancer adjuvant/neoadjuvant has successfully initiated phase III key experiments, and 7 other products are in different clinical stages. The company is accelerating the development of the next-generation tumor immune checkpoint inhibitor 3D057 and the next-generation tumor vaccine 3D124.

Tumor vaccines use tumor antigen epitopes to activate CD8+ T cells, activate active immunity to kill cancer cells, cause systemic tumor regression and prolong the patient's lifespan. Although existing immunotherapy has achieved remarkable results in the field of tumor treatment, cancer vaccines have unique advantages. They can target intracellular antigens such as tumor-specific surface antigens, and may even trigger new tumor-specific T cell responses. The company has a forward-looking layout of peptide tumor vaccines and mRNA cancer vaccines.

Furthermore, the company is building an internal production facility in Xuzhou, Jiangsu Province. The manufacturing system and facilities for the entire drug development process (including chemical drugs and biological agents) meet current GMP to meet strict global standards. The company's GMP compliant manufacturing facilities are designed and verified according to the regulations of the FDA, EMA and the China National Drug Administration to support the entire drug development process from drug discovery to development, GMP compliance pilots and commercial production. In order to prepare for the massive demand for pharmaceuticals after commercialization, the company purchased land use rights with a total area of 65,637.97 square meters in Xuzhou. The company has obtained a construction permit and has begun construction of a new production facility in Xuzhou.

Looking ahead, the company will continue to work to achieve the strategic goals of sustainable growth and global innovation. Therefore, the company will further accelerate product development and commercialization processes, improve operational efficiency, and continue to launch innovative drugs by relying on advanced R&D platforms and working hand in hand with partners. The company is exploring cell therapies by building a universal mRNA discovery platform. The company will launch the first mRNA oncology vaccine, 3D124, to the clinical stage in the near future.

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