Ribo Life Science Forecasts Core Product Sales to Exceed RMB 4.6 Billion by 2030

　　Technologies in the Spotlight

Ribo Life Science is an innovative enterprise dedicated to the research and development of oligonucleotide therapeutics. The company has independently developed and established a comprehensive R&D platform for oligonucleotide drugs, featuring an integrated full-technology chain that covers the entire lifecycle from early-stage research to industrialization. This platform comprises six core technological platforms: oligonucleotide sequence design and high-throughput screening, drug delivery technologies, stabilization modifications, bioanalysis, pharmaceutical development, and monomer R&D.

According to the prospectus, oligonucleotide therapeutics represent an entirely novel drug class, distinct from small-molecule drugs and antibody-based therapies, offering unique advantages. The primary technical challenges in oligonucleotide drug development lie in delivery technologies, stabilization modifications, and pharmaceutical research, with oligonucleotide delivery being a bottleneck constraining global industry advancement. While liver-targeted delivery of oligonucleotides has achieved technological breakthroughs, delivery to non-hepatic tissues remains unresolved, posing a major challenge to the widespread application of oligonucleotide therapeutics. Extensive innovative research on oligonucleotide delivery to organs and tissues such as the lungs, central nervous system, cardiovascular system, kidneys, and eyes has been conducted worldwide, yielding positive progress. The company has independently developed GalNAc-based liver-targeted delivery technology.

The company’s technology has drawn the attention of regulators. The inquiry letter requires the company to provide supplementary disclosures on the development and iteration of key technologies for small nucleic acid drugs, such as delivery systems, stabilization modifications, and pharmaceutical research; the classification of technology types or generations; the position of the company’s independently developed technological capabilities within the industry; a comparison with competing products; and whether there is a risk of being superseded or phased out by other technologies in recent years.

The Company stated that delivery technologies, modification technologies, and pharmaceutical research constitute the most critical technical challenges in small nucleic acid drug development, as well as its core technological platforms. Benchmarking against the global forefront of innovation in small nucleic acid technologies, the Company has, through years of development, established an independently controlled, fully integrated small nucleic acid drug R&D platform across the entire technology chain. This has laid the technical foundation for the Company’s establishment and growth within the industry, creating a robust technological barrier. All technologies currently employed by the Company are the most mainstream internationally, maintaining synchronization and generational parity with global standards, thereby representing the most advanced level of small nucleic acid therapeutics. These technologies exhibit “platform-based” characteristics; once the platform advantage is established, they enable the efficient and continuous development of small nucleic acid drugs.

Furthermore, the Company has implemented comprehensive protective measures for its core technologies. Through patent applications, it has secured coverage for key areas including oligonucleotide drug compound structures, oligonucleotide drug delivery technologies, oligonucleotide stabilization modification technologies, and oligonucleotide synthesis technologies. Meanwhile, for core technologies unsuitable for patent protection, the Company has adopted stringent trade secret safeguards and established robust management systems, thereby forming an all-encompassing protection framework for its core technologies.

As an innovative biopharmaceutical enterprise, the company places great emphasis on technological research and development (R&D) and the enhancement of its innovation capabilities. The company has assembled a R&D team led by PhDs from renowned domestic and international universities, with members possessing work experience in multinational pharmaceutical companies. This team brings extensive expertise across multiple disciplines, including biology, chemistry, medicine, pharmacy, pharmacology, toxicology, and clinical research, demonstrating strong scientific research capabilities. The company will continue to invest in R&D to ensure its technological leadership within the industry and avoid being phased out due to technological iteration.

　　Vast Market Potential

As of the date of signing the prospectus, the company is conducting tenThe remaining funds are allocated to the research and development of products in the pipeline. Among them, SR061 for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION) is in Phase II/III clinical trials; SR062 for the treatment of type 2 diabetes is in Phase II clinical trials; SR063 for the treatment of AR-V7-positive metastatic castration-resistant prostate cancer (mCRPC) is in Phase IIa clinical trials; and SR016 for the treatment of chronic hepatitis B is at the stage of Investigational New Drug (IND) application.

The market potential of the company’s core products under development has also drawn the attention of regulators. The inquiry letter requires the company to make prudent and reasonable forecasts of the market potential for its core products under development, taking into account factors such as R&D progress, target patient populations and their proportions, competitive landscape, competitive advantages and disadvantages, pricing and reimbursement policies, insurance coverage, and sales performance of already marketed drugs. The company must also explain whether the parameters, underlying data, assumptions, and models used in estimating market potential are prudent and reasonable, and whether the sources of relevant parameters and data are objective and authoritative; it should disclose related risks as appropriate based on actual circumstances.

The company stated that the projected sales volume of its core products in the currently targeted indications is expected to range between RMB 4.663 billion and RMB 8.864 billion by 2030. In the future, as scale expands and financial resources permit, the company will further develop and expand the indication scope for multiple product candidates, thereby unlocking additional market potential. Therefore, the market opportunity for the company’s core products is substantial.

The Company highlights risks, noting that the market potential of its core products under development is closely linked to the patient populations covered by the indications approved upon product launch. Generally, the specific indications listed on the future drug label are correlated with the clinical trial design (including patient inclusion/exclusion criteria and the design of clinical trial endpoints). The precise scope of indications must be determined through iterative communications with regulatory authorities during the New Drug Application (NDA) stage. When forecasting market potential, the indication-specific patient populations selected by the Company are consistent with the clinical trial design; however, there is a possibility that regulatory authorities may not approve the Company’s proposed segmentation of patient populations for indications during the NDA review process. In summary, following the approval and launch of the Company’s core products under development, uncertainties regarding the scope of indications included in the labeling will lead to certain uncertainties in their market potential.

　　Not Yet Profitable

The Company proposes to adopt the fifth set of listing standards for the STAR Market. Since its establishment, the Company has been continuously engaged in the research and development of innovative drugs and technologies, but has not yet achieved commercial sales of its products. During 2017–2019 and from January to September 2020 (collectively referred to as the “Reporting Period”), the net profit attributable to shareholders of the parent company was RMB -73.4114 million, RMB -98.6604 million, RMB -134.3541 million, and RMB -191.4589 million, respectively; the net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses was RMB -81.7260 million, RMB -111.7534 million, RMB -140.7701 million, and RMB -135.5491 million, respectively. As of September 30, 2020, the Company’s accumulated undistributed profits amounted to RMB -68.6850 million.

The Company stated that it has not yet achieved profitability and has accumulated uncovered losses, primarily because it has been engaged in drug development since its establishment. Such projects are characterized by long development cycles and substantial capital investment. During the reporting period, the Company remained in the product development phase and had not yet achieved commercialization; its products under development had not generated any operating revenue. The continuous increase in the Company’s R&D expenditures, coupled with share-based compensation expenses for core employees, has led to a growing accumulation of uncovered losses. The Company will continue to invest in the research and development of its pipeline products, out-license commercialization rights at appropriate stages, and carry out ongoing market promotion after regulatory approval for marketing is obtained. If the out-licensing of commercialization rights falls short of expectations, or if the Company’s revenue fails to grow as anticipated following commercialization of its drugs, this may result in further expansion of its losses.