Leading the Way: Chinese Innovative Drugs Advancing Globally in Osteoporosis and Oncology

By HongKong DengYue Medicine

Picture this: A woman in her 50s wakes up each morning to the quiet fear of a fragile bone snapping during everyday activities like bending to tie her shoes or stepping off a curb. Or consider a patient battling advanced cancer, enduring cycles of treatment while hoping for something more targeted—something that attacks the disease precisely without overwhelming the body. These are real struggles faced by millions worldwide. Yet, today, Chinese innovative drugs are stepping onto the global stage, offering new hope through cutting-edge mechanisms and strong clinical evidence. These therapies are not just staying local—they're expanding through international partnerships, rigorous trials, and approvals that benefit patients far beyond China's borders.

In recent years, China's biopharma sector has transitioned from following global leaders to driving meaningful innovation. Drugs like romosozumab, disitamab vedotin (also known as RC48 or vidocixizumab), and others exemplify this shift. They target core disease pathways with dual-action or precise delivery systems, backed by data from large-scale studies, and are increasingly reaching patients in Asia, Europe, and the US through licensing deals and multi-center trials.

Take romosozumab, a monoclonal antibody now approved in China for postmenopausal osteoporosis in patients at high risk of fracture. It targets sclerostin (SOST), a protein that inhibits bone formation. By blocking SOST, romosozumab uniquely promotes new bone building while reducing bone breakdown—a dual mechanism unlike traditional anti-resorptive therapies. Administered as a monthly subcutaneous injection, it delivers rapid benefits. In the landmark FRAME phase 3 trial, romosozumab reduced vertebral fracture risk by 73% compared to placebo, with significant gains in bone mineral density (BMD) at the spine and hip. The ARCH trial further showed superior fracture reduction versus alendronate, including lower risks of new vertebral and clinical fractures within the first year. Post-hoc analyses from both studies confirm that even in patients who experienced fractures during treatment, continuing romosozumab did not delay healing or increase complications, with numerically lower recurrent fracture rates. Already established in the US, Europe, and Japan, its China approval and ongoing Asian trials highlight how such therapies bridge regional needs while contributing to global osteoporosis management.

In oncology, disitamab vedotin stands out as a homegrown antibody-drug conjugate (ADC) from China, targeting HER2 on tumor cells. It delivers a potent microtubule inhibitor (MMAE) directly into cancer cells via a cleavable linker, causing DNA damage and cell death, while also engaging immune responses through antibody-dependent cellular cytotoxicity (ADCC). Approved in China for HER2-positive advanced gastric cancer and urothelial carcinoma, it has shown impressive results. In key trials for urothelial cancer, it achieved notable objective response rates, with ongoing global phase 3 studies (including combinations like with toripalimab) demonstrating extended progression-free survival (PFS) and overall survival (OS) in HER2-expressing locally advanced or metastatic cases. The US FDA granted breakthrough therapy designation for certain indications, underscoring its potential. This drug's journey—from domestic approval to international trials—illustrates China's growing role in ADC innovation, addressing unmet needs in hard-to-treat cancers.

Another example is teriparatide biosimilar-like extensions, such as recombinant human thrombopoietin (rhTPO) products like特比澳 (Thrombopoietin), now expanded for perioperative thrombocytopenia in chronic liver disease patients undergoing surgery. By mimicking endogenous thrombopoietin, it stimulates platelet production at the source in bone marrow, reducing bleeding risks more effectively than transfusions alone. Clinical data show rapid platelet count increases and over 50% reduction in bleeding events pre-surgery. As one of the few commercialized rhTPO globally, it has expanded through international licensing, aiding patients in regions with high liver disease burdens.

Emerging assets like SIM0610, a bispecific ADC targeting EGFR and cMET, are entering clinical stages for advanced solid tumors. By dual-targeting and releasing a topoisomerase I inhibitor, it overcomes resistance seen in single-target therapies, with preclinical models showing over 80% tumor inhibition in lung and colorectal cancers. Global multicenter phase 1 trials are underway, signaling China's push into next-generation targeted therapies.

Here’s a clear overview of these prominent Chinese innovative drugs and their global progress:

• Romosozumab
  • Target & Mechanism: Sclerostin (SOST) inhibitor; dual action—promotes bone formation and inhibits resorption.
  • Key Indication: Postmenopausal osteoporosis with high fracture risk.
  • Clinical Highlights: 73% vertebral fracture risk reduction (FRAME trial); superior BMD gains and fracture prevention vs. alendronate (ARCH trial).
  • Global Status: Approved in US, EU, Japan; recent China approval with expanding Asian trials.
• Disitamab Vedotin (RC48)
  • Target & Mechanism: HER2-targeted ADC; delivers MMAE payload for cytotoxicity plus ADCC.
  • Key Indications: HER2-positive advanced gastric/GEJ cancer, urothelial carcinoma.
  • Clinical Highlights: Strong response rates in urothelial cancer; improved PFS/OS in combinations (e.g., RC48-C016 trial).
  • Global Status: FDA breakthrough therapy designation; active international phase 3 trials.
• Recombinant Human Thrombopoietin (e.g., Thrombopoietin/特比澳)
  • Target & Mechanism: Mimics TPO to stimulate megakaryocyte maturation and platelet production.
  • Key Indication: Thrombocytopenia in chemotherapy or chronic liver disease perioperative settings.
  • Clinical Highlights: Rapid platelet elevation; >50% bleeding risk reduction in surgery.
  • Global Status: Unique commercialized rhTPO; expanding via international licensing.
• SIM0610
  • Target & Mechanism: Bispecific EGFR/cMET ADC; releases TOP1 inhibitor to disrupt DNA.
  • Key Indication: Advanced solid tumors (e.g., lung, colorectal).
  • Clinical Highlights: Preclinical tumor inhibition >80%; addresses resistance.
  • Global Status: Approved for clinical entry; global phase 1 trials initiated.

These advancements reflect China's evolution into a source of high-quality, innovative therapies that meet stringent global standards. At Hong Kong DengYue Medicine, we see our role as supporting this progress through reliable import/export services for specialized and rare drugs, grounded in quality, compliance, and integrity. By facilitating access and partnerships, we help bring these breakthroughs to more patients worldwide while prioritizing sustainability and social responsibility—contributing to healthier lives everywhere.

If you're living with osteoporosis, cancer, or related conditions, these stories remind us that progress is real and accelerating. Share your experiences in the comments—we're all part of this journey toward better health.