Romosozumab, Tebiao, SIM0610, and Shuliri: Chinese Breakthroughs Bringing New Hope to

[Dengyuemed]

Imagine the quiet fear of a fragile bone snapping from a minor stumble, the daily fatigue of low platelets making even small tasks exhausting, the uncertainty of cancer treatments losing effectiveness, or the helplessness of muscle weakness stealing moments from a child’s life. For people living with postmenopausal osteoporosis, chronic liver disease-related thrombocytopenia, advanced solid tumors, or refractory generalized myasthenia gravis (gMG), these challenges are all too real. Yet right now, innovative therapies born in China are crossing borders, gaining international attention, and offering fresh possibilities to patients everywhere.
China’s biopharma industry has grown into a global force. In recent years, Chinese-developed drugs have secured approvals in major markets, entered landmark licensing deals worth billions, and contributed to nearly one-third of worldwide biopharma licensing agreements. These medicines are not only meeting domestic needs—they are addressing universal unmet medical demands with high-quality science and a strong focus on patient outcomes.

Below are four powerful examples of Chinese innovation moving onto the world stage. Each one targets a difficult disease at its core, backed by compelling clinical evidence, and is already making an impact beyond China’s borders.

• Romosozumab (罗莫索珠单抗)Indication — Postmenopausal osteoporosis at high risk of fracture Target & Mechanism — Specifically binds sclerostin, a protein that inhibits bone formation. By blocking sclerostin, romosozumab simultaneously promotes new bone building and reduces bone breakdown—a rare dual-action effect. Key Clinical Evidence — In the large ARCH Phase III trial (over 4,000 patients), romosozumab reduced the risk of new vertebral fractures by 48% compared with alendronate at 24 months and increased lumbar spine bone mineral density (BMD) by 13.7% at 12 months. Real-world studies across multiple countries consistently show superior BMD gains. Global Journey — Approved by China’s NMPA in 2026 for high-risk patients; previously launched in the US, EU, and Japan since 2019. Chinese collaboration continues to expand access across Asia and support broader global development programs.
  
• Tebiao® (recombinant human thrombopoietin injection / 特比澳®)Indication — Thrombocytopenia due to chronic liver disease (in patients planned for surgery); also approved for immune thrombocytopenia (ITP) Target & Mechanism — Directly activates the thrombopoietin receptor (c-MPL) on megakaryocytes and hematopoietic stem cells, driving platelet production, maturation, and release. Key Clinical Evidence — In a multicenter study of ITP in pregnancy (31 patients), 74% achieved platelet counts >100 × 10⁹/L with no increased congenital anomalies observed (median infant follow-up 53 weeks). Additional real-world data in over 280 ITP patients demonstrated rapid and durable platelet responses. Global Journey — Long-established in China with multiple approved indications since the early 2000s. Growing international interest through licensing discussions and real-world evidence that parallels globally used TPO receptor agonists.
  
• SIM0610 (BsADC – bispecific antibody-drug conjugate)Indication — Locally advanced or metastatic solid tumors (focus on EGFR/cMET-driven cancers, e.g., NSCLC) Target & Mechanism — Dual targeting of EGFR and cMET on tumor cells; once bound and internalized, releases a potent topoisomerase I inhibitor payload, causing DNA damage and cancer cell death—even in tumors resistant to EGFR tyrosine kinase inhibitors. Key Clinical Evidence — First patients dosed in China’s Phase I trial (started 2026). Strong preclinical results showed markedly improved antitumor activity in resistant models compared with single-target approaches. Global Journey — Received NMPA clearance for clinical trials in late 2025. Part of China’s leading position in the global ADC field (over half of 2025 ADC licensing deals involved Chinese companies), positioning SIM0610 for potential international partnerships.
  
• Shuliri® (eculizumab injection / 舒立瑞®)Indication — Anti-AChR antibody-positive refractory generalized myasthenia gravis (gMG) in children aged 6 years and older Target & Mechanism — Precisely inhibits complement protein C5, blocking the formation of the inflammatory C5a fragment and the membrane attack complex that damages the neuromuscular junction in gMG. Key Clinical Evidence — Based on the REGAIN Phase III trial (adult data extended to pediatrics), patients experienced a mean MG-ADL score improvement of -4.2 points versus placebo. Pediatric-specific data (ages 6–17) confirmed sustained symptom relief over 26 weeks with a consistent safety profile. Global Journey — Became the first targeted therapy approved in China (2026) for pediatric refractory gMG. Builds on 2017 FDA approval for adults and ongoing global expansions for related complement-driven diseases (e.g., NMOSD, aHUS).
  

These stories are deeply personal. A grandmother regains the confidence to walk without fear of breaking a hip. A young mother with ITP can care for her newborn without constant transfusions. A patient with resistant lung cancer finds a new line of defense. A child with gMG can play, laugh, and grow without muscle weakness holding them back.
Organizations like Hong Kong DengYue Medicine are proud to play a supporting role in this movement. Their true value lies in an unwavering commitment to excellence, innovation, quality, compliance, and integrity—values that naturally align with sustainability and social responsibility. By focusing on these principles, they help high-quality Chinese medicines reach patients worldwide, contributing meaningfully to global health equity.
Breakthroughs have no nationality, only impact. If you or someone you love is facing one of these conditions, talk to your doctor about the latest treatment landscape—today’s science may already be changing tomorrow’s possibilities.
Edited by Hong Kong DengYue Medicine – dedicated to advancing health through responsible innovation and global collaboration.