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Gene Editing Drug Developer
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Recently, Sirius Therapeutics officially submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs, Haitong International, and HSBC serving as joint sponsors. The prospectus shows that Sirius Therapeutics was established in 2021 and is committed to the development of siRNA therapies.
From the perspective of equity structure, the company boasts a rather luxurious shareholder lineup. The company itself was jointly founded by OrbiMed Entities, a top global healthcare investment institution, and Creacion Ventures, with the two collectively holding over 40% of shares. Additionally, Image Frame Investment, under the internet giant Tencent, holds 8.14% of shares, while funds under Hancong Capital, which focuses on the healthcare sector, collectively hold more than 13%. With strong capital support, Sirius Therapeutics' valuation reached an impressive $2.53 billion (approximately RMB 1.8 billion) after its Series B2 financing round in April 2025.
However, on the B-side of the glamorous capital background, the company still faces many hidden concerns. In terms of products, the core product is blocked by giants in the front and closely chased from behind. None of its pipelines have crossed the "valley of death" of Phase II clinical trials for new drug development, and progress lags behind. In terms of cooperation, to alleviate an urgent need, the company has ceded half of the rights and future decision-making power of its core product, deeply tying its fate to others. Financially, the first-half profit turnaround was just a flash in the pan, with real product revenue still far out of reach. Regarding intellectual property, several core patents remain unresolved, and the technological moat has yet to be established.
A fleeting return to profitability: Half of the potential gains from core products have already been relinquished
Since no products have entered the commercialization stage, all revenue sources of Sirius Therapeutics come from external licensing collaborations, making the company's income highly uncertain. In 2023 and 2024, the company recorded net losses of 309 million yuan and 342 million yuan respectively, with a total accumulated loss of 651 million yuan. However, in the first half of 2025, the company’s performance reversed, achieving a net profit of 34.461 million yuan and turning profitable for the first time.
However, a further analysis of its profit structure reveals that this profitability mainly relies on non-recurring items. In the first half of 2025, the company's other income and gains reached 144 million yuan, a significant increase from 4.508 million yuan in the same period last year. Among these, financial assets measured at fair value with changes recognized in profit or loss brought approximately 140 million yuan in fair value gains.
This revenue is mainly derived from the strategic cooperation reached in May 2025 between the company and CRISPR Therapeutics, a global leader in gene editing. According to the Global Co-development and Commercialization Agreement signed by both parties, Sirius Therapeutics granted CRISPR Therapeutics the rights to develop siRNA therapies including SRSD107, and in return received a $25 million upfront payment, CRISPR shares worth $70 million, as well as potential future milestone payments of up to $800 million.
This collaboration not only brought direct financial revenue to Sirius Therapeutics but also, due to the rise in CRISPR Therapeutics' stock price, significantly increased the fair value of its holdings, reflecting substantial gains in the financial statements. Thus, the profitability achieved by Sirius Therapeutics this time essentially reflects the capital market's recognition of the value of its partner, CRISPR Therapeutics, rather than its own ability to commercialize products and generate sustainable income. The turnaround from loss to profit may only be a fleeting phenomenon.
According to the agreement between Sirius Therapeutics and CRISPR Therapeutics, Sirius Therapeutics will only receive half of the global commercial revenue of SRSD107 in the future. For a company with no current revenue, giving up half of the potential earnings of its core product in advance undoubtedly represents a significant loss of future value.
Core Products Face "Double-Sided Pressure" as 32 Key Patents Remain Unapproved
From a product perspective, according to the prospectus, Sirius Therapeutics currently has one core product and two key products. Among them, the core product SRSD107 is an siRNA drug targeting coagulation factor XI, which is currently undergoing a Phase II multicenter clinical trial in Europe for the indication of venous thromboembolism.
The highlight is that Factor FXI mainly participates in pathological thrombosis, while its role in physiological hemostasis is limited. Therefore, theoretically, SRSD107 can achieve effective anticoagulation without significantly increasing the risk of bleeding, which is expected to address the clinical pain point of high bleeding risk associated with existing anticoagulants (such as apixaban and rivaroxaban).
The key product SRSD216 is an siRNA drug targeting lipoprotein(a), used for treating hyper-Lp(a)emia, which is closely associated with cardiovascular disease risk. It has simultaneously entered Phase IIa clinical trials in both China and the U.S. The key product SRSD384 is an INHBE-targeting drug for obesity, aiming to preserve muscle while reducing fat through non-enteroinsular pathways, and is currently in the IND application stage.
Behind the promising technological narrative, it is not difficult to find that almost all of the company's pipelines are in the early stages. New drug development is notoriously fraught with challenges, and Phase II clinical trials are a critical stage for validating drug efficacy as well as the phase with the highest failure rate, often referred to as the "valley of death." None of Sirius Therapeutics' products have yet passed this stage, and its key product, SRSD384, has not even entered clinical trials, making its path to commercialization distant and uncertain.
As for SRSD107, which is closest to commercialization, it also faces considerable pressure. Globally, the FXI/FXIa inhibitor field has become quite crowded. Antibodies or small molecule drugs such as Novartis' Abelacimab, Bayer's Asundexian, and Johnson & Johnson's Milvexian have all entered Phase III clinical trials. Although these drugs have different mechanisms of action from SRSD107, they share the same target, have highly overlapping indications, and are at least one stage ahead in terms of progress.
In the domestic market,Hengrui MedicineSHR-2004 has also entered Phase III clinical trials. In addition, companies such as Regeneron, Ribo Biotech, and Alphamab Oncology have similar or related target products, with research and development progress mostly ahead of SRSD107.
At the same time, SRSD107 also needs to face the competition from existing standard therapies. Apixaban's global sales exceeded 20 billion US dollars in 2024, establishing deep physician prescription habits and market barriers. As a drug with a completely new mechanism, SRSD107 needs to invest substantial resources and time into market education and clinical promotion to prove its superior value over existing therapies.
Moreover, as of the latest practicable date, Sirius Therapeutics owned 65 patents and patent applications, but only one of them, the "polynucleotide construct" patent, has been granted. This includes 32 patents that are significant to the group's business, all of which are still "pending" globally. In the biopharmaceutical field, where technology evolves rapidly and patent litigation is frequent, especially in the fiercely competitive siRNA sector, the potential risks associated with core patents not being authorized cannot be ignored.
Editorial Responsibility: Company Observation