Recently, Shenyang Sansheng Pharmaceutical announced that its core product, recombinant human thrombopoietin injection (Tebio), has been officially approved by the National Medical Products Administration for a new indication: for adult patients with chronic liver disease-related thrombocytopenia (CLDT) who are scheduled to undergo surgery (including diagnostic procedures) .

It is worth mentioning that, according to data from PharmNet, TEBIA's sales in domestic public medical institutions exceeded 5 billion yuan in 2024. This new indication is its fourth approved indication, which will further consolidate its leading position in the thrombocytopenia treatment market.

01
The Road to Glory

The story of TBIA began in the early days of China's biopharmaceutical industry. In 2005, when imported biopharmaceuticals dominated the Chinese market, 3SBio's independently developed recombinant human thrombopoietin injection was approved for marketing, becoming the world's only commercially available recombinant human thrombopoietin product and China's first Class 1 new drug biological product approved in China.

The innovation of this drug lies in its structural similarity to endogenous TPO, which activates intracellular signaling pathways, providing comprehensive protection and protection for megakaryocytes. Simply put, unlike traditional treatments that rely on emergency blood transfusions, it addresses the root cause by promoting hematopoiesis— by activating the body's own platelet production mechanism, it fundamentally solves the problem of thrombocytopenia .

This breakthrough, "from zero to one," granted TEBIA nearly a decade of exclusive market access in the field of post-chemotherapy thrombocytopenia (CIT), with sales steadily climbing from tens of millions initially, laying the first cornerstone.

The real leap forward began with the second strategic expansion of its indications. In 2018, TEBIO was approved for the indication of primary immune thrombocytopenic purpura (ITP) in adults. This decision was quite visionary: ITP is an autoimmune disease with an annual incidence of approximately 5-10 per 100,000 adults, and patients require long-term maintenance therapy.

As a result, its market shifted from short-term emergency relief to long-term management , and the clinical value of TEBIA was redefined. More importantly, the success in the ITP field made 3SBio see a huge gap in the pediatric market.

In April 2024, TBEA received approval for the pediatric ITP indication, becoming the only rhTPO drug in China to receive this approval. This designation provides it with strong barriers to entry and significant advantages. Phase III clinical data for pediatric ITP showed that the efficacy rate in patients aged 6 years and older was significantly better than placebo, with a good safety profile.

However, 3SBio's ambitions don't stop there.

02
Breakthrough in New Indications

Chronic liver disease-associated thrombocytopenia (CLDT) is a long-underestimated clinical challenge. Data shows that the prevalence of CLDT in patients with chronic liver disease ranges from 6% (non-cirrhotic) to 78% (cirrhotic).

The surgical aspect is even more challenging. When these patients require invasive procedures such as liver biopsy, interventional therapy, or even liver transplantation, platelet counts significantly increase the risk of bleeding. Traditional solutions are limited to two options: either risk surgery or platelet transfusion. However, platelet products are scarce, have a short shelf life, and carry risks of transfusion reactions and infections, often leaving clinicians in a predicament of having no blood available .

The Terbian CLDT Phase III clinical trial was designed to address this need. The study employed a multicenter, randomized, double-blind, placebo-controlled gold standard, enrolling adult CLDT patients scheduled for elective invasive surgery. The primary endpoint was the proportion of participants maintaining a perioperative platelet count ≥50 × 10⁹/L, directly corresponding to the clinical decision threshold.

The results showed that the proportion of subjects maintaining a perioperative platelet count ≥50×10⁹/L in the experimental group (rhTPO) was 85.00% (95% CI: 75.26, 92.00), while it was 12.50% in the control group (95% CI: 4.19, 26.80). The difference in response rate between the two groups (experimental group - control group) was 67.90% (95% CI: 51.60, 84.20; P<0.0001). These results indicate that the response rate in the experimental group was significantly increased compared with the control group, and the primary efficacy endpoint was achieved, demonstrating superiority. There was no significant difference in the incidence and severity of adverse events between the experimental and control groups.

Regarding the approval process, 3SBio submitted its marketing application for the CLDT indication in August 2024 and recently received approval from the National Medical Products Administration. Following this approval, TBEA becomes the only CLDT-approved platelet-stimulating drug in China.

From application submission to approval, from clinical trials to market forecasting, its breakthrough path for the CLDT indication is clear, providing concrete support for TEBIA to move from a sales scale of 5 billion yuan to a higher goal.

03
3SBio's Growth Flywheel

The success of TBIA did not stop 3SBio's research and development efforts. According to its 2025 semi-annual report, 3SBio has 30 products in its R&D pipeline, with 13 new drugs having advanced to Phase III clinical trials or the New Drug Application (NDA) stage, forming a strong product portfolio.

In oncology , the PD-1/HER2 bispecific antibody SSGJ-705 has been approved for a Phase II clinical trial for the treatment of advanced malignant solid tumors expressing HER2. Preclinical studies showed that SSGJ-705 exhibited better synergistic effects and efficacy compared to the combination of two corresponding monoclonal antibodies for PD-1 and HER2. The PD-1/PD-L1 bispecific antibody SSGJ-706 has received approval for two Phase II clinical trials for the treatment of gastrointestinal tumors and non-small cell lung cancer.

The autoimmune pipeline is progressing rapidly, with several products nearing harvest time. New Drug Applications (NDAs) have been submitted and accepted for two indications: IL-17A monoclonal antibody SSGJ-608 for the treatment of plaque psoriasis and IL-1β monoclonal antibody SSGJ-613 for the treatment of acute gouty arthritis. The Phase III clinical trial of IL-4Rα monoclonal antibody SSGJ-611 for the treatment of adult atopic dermatitis has met its primary endpoint.

In the nephrology field, long-acting products are comprehensively positioned to address the indications of dialysis patients and anemia, further strengthening the company's advantages in the field. The long-acting erythropoietin SSS06 for the treatment of dialysis-induced anemia has submitted an NDA to the National Medical Products Administration and has been accepted; a Phase II clinical trial for chemotherapy-induced anemia (CIA) is underway. The HIF inhibitor SSS17 has entered Phase II clinical research for the application of renal anemia in non-dialysis patients and anemia after orthopedic surgery.

In the future, with the successive approval of multiple Phase III products, 3SBio is expected to transform into a multi-engine growth platform pharmaceutical company, with new pipelines replicating the path of blockbuster products in their respective fields, forming a continuously iterating product matrix.

04
Conclusion

From single-product-driven growth to pipeline synergy, 3SBio reflects the leap of Chinese innovative pharmaceutical companies from isolated breakthroughs to mature platform-based operations. While its terbinafine plasminogen toxicity product (TBNT) firmly holds the leading position in the thrombocytopenia market and continues to unleash its sales potential of tens of billions of yuan, its R&D pipeline has quietly accumulated 2-3 candidate products with the potential to reach 5 billion yuan in sales. This self-iterative capability, fueled by star products and followed by a successor pipeline, constitutes 3SBio's core barrier and true moat in navigating economic cycles.

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