Despite fierce market competition, SiliDi Pharmaceuticals delivered a "cost reduction and efficiency improvement" report card in 2024: revenue declined but losses narrowed significantly, sales of its core product Envida grew by 15.9% in the second half of the year against the trend, and the mRNA tumor vaccine pipeline achieved key breakthroughs.

How will this innovative pharmaceutical company make a comeback in the future?

Sales of core products declined

According to the financial report, in 2024, SiliDi achieved revenue of approximately RMB 446 million, a year-on-year decrease of 29.8%; gross profit was RMB 409 million, a year-on-year decrease of 30.2%. In addition, thanks to a significant reduction in R&D expenses and sales and marketing expenses (down 57.5% and 37.7% respectively), the full-year net loss narrowed to RMB 199 million, a year-on-year decrease of 64.6%.

Subcutaneous injection of PD-L1 Envolimab (trade name: Envida) is the only commercialized product of SilDi, and the company's revenue comes entirely from the sales of this product. SilDi's revenue declined mainly due to the intensified competition in the PD-1/L1 market.

But it is worth noting that Envida's sales in the second half of the year increased by 15.9% month-on-month, sending a positive signal.

As the first subcutaneously injected PD-L1 inhibitor in China, Envolizumab faces fierce competition, but its clinical data in the fields of lung cancer, biliary tract cancer, and gastric cancer are impressive.

In addition, SilDi Pharmaceuticals is expanding the commercialization of Envolizumab from China to the world. In January 2024, the company reached a licensing agreement with India's Glenmark, authorizing it to develop and commercialize the drug in Asia Pacific, the Middle East and other regions. In the same year, the product was successfully launched in the Macau market, marking a key step in the company's internationalization strategy.

Can betting on mRNA tumor vaccines turn things around?

The company is accelerating the layout of cutting-edge technologies, and its differentiated pipeline is beginning to show results.

Currently, SiliDi has a diversified product pipeline consisting of 13 products, including potential pipelines such as mRNA tumor vaccines, nuclear medicines, and bispecific antibodies.

mRNA tumor vaccine 3D124: is an "off-the-shelf" tumor therapeutic vaccine for multiple tumor indications. Compared with personalized tumor vaccines, 3D124 is faster and cheaper to apply clinically.

SiliDi Pharmaceuticals has independently developed an AI-driven tumor antigen prediction platform 3D-PreciseAg, which, combined with its own intellectual property lipid nanoparticle (LNP) delivery platform, is reshaping the mRNA drug development model. This platform not only shortens the R&D cycle, but also significantly reduces development costs, paving the way for the commercialization of personalized tumor vaccines.

3D124 is the first mRNA tumor vaccine developed by SilvoDi based on the mRNA-LNP platform. It can target multiple tumor antigens, especially tumor-driving mutations, including KRAS, NRAS EGFR, etc., and has shown strong anti-tumor effects in preclinical studies.

SiliDi plans to submit an IND application to the FDA and CDE this year and build a treatment matrix by combining with PD-1 drugs.

Nuclear medicine 3D1015: It is a new molecule developed based on the small molecule drug 3D011 targeting prostate-specific membrane antigen (PSMA), and is intended for the treatment of metastatic castration-resistant prostate cancer.

Preclinical studies have shown that 3D1015 still has a significant tumor inhibitory effect at one-tenth the dose of Pluvicto, and the tumor inhibitory effect of this molecule exceeds that of Pluvicto at half the dose of Pluvicto. It is expected to become a new generation of radionuclide-conjugated drugs, with the potential to improve the safety and effectiveness of PSMA radioligand therapy and significantly reduce costs.

Bispecific antibody 3D057: A bispecific antibody targeting PD-L1 and CD3 developed based on the ALiCE platform. A relatively robust production process has been developed; the plan for non-clinical studies has been determined and is progressing steadily.

KRAS inhibitor 3D062: It is a KRAS mutation inhibitor developed internally by Siludy, and a new Chinese patent application was submitted on May 30, 2024.

Despite facing fierce competition in the PD-(L)1 market, the expansion of Envolimab's indications, the clinical advancement of mRNA tumor vaccines and the progress of other innovative pipelines will bring new growth momentum to the company in the future.

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