I. Introduction: The Ultimate Validation
In the world of evidence-based medicine, inclusion in clinical practice guidelines is the highest form of recognition. When a drug is recommended by a professional society's guidelines — particularly international guidelines — it signals that the evidence is sufficiently robust to change clinical practice.
In 2026, Chinese innovative drugs achieved a series of historic firsts in international and regional clinical guidelines. From APASL guidelines for hepatitis B to CSCO guidelines for lung cancer and gastric cancer, Chinese-origin drugs are now being recognized at the highest levels — marking a new era for Chinese biopharma.
• TMF (恒沐®) – First Chinese oral anti-HBV drug included in APASL guidelines (I级推荐)
• Ivonescimab (依沃西®) – PD-1/VEGF bispecific antibody upgraded to I级推荐 in CSCO NSCLC guidelines
• Satri-cel (舒瑞基奥仑赛) – First CAR-T for gastric cancer included in CSCO gastric cancer guidelines
• Xuebijing (血必净) – Included in 2026 International Sepsis Guidelines
II. APASL Guidelines (2026): TMF – The First Chinese Anti-HBV Drug to Earn Global Recommendation
In April 2026, the Asian Pacific Association for the Study of the Liver (APASL) published its 2026 Clinical Practice Guidelines for the Management of Chronic Hepatitis B — the first major update in 11 years.
For the first time, a Chinese-developed oral anti-HBV drug was included in the guidelines: Tenofovir Amibufenamide (TMF, brand name: 恒沐® / Henmu®), developed by Hansoh Pharmaceutical (翰森制药).
Key Details
| Aspect | Details |
|---|---|
| Drug | Tenofovir Amibufenamide (TMF, 恒沐®) |
| Developer | Hansoh Pharmaceutical (翰森制药) |
| Guideline | APASL 2026 Chronic Hepatitis B Guidelines |
| Recommendation Level | I级推荐 (Class I Recommendation) |
| Significance | First Chinese oral anti-HBV drug included in APASL guidelines |
Clinical Evidence
TMF is a novel nucleotide analog with a mechanism of action similar to tenofovir disoproxil fumarate (TDF) but with an improved pharmacokinetic and safety profile. Key clinical data supporting the recommendation include:
- Comparable efficacy to TDF in suppressing HBV DNA
- Superior renal safety: Lower incidence of renal toxicity compared to TDF
- Better bone mineral density: Less impact on bone health compared to TDF
- Favorable lipid profile: No significant impact on serum lipids
Why This Matters
The APASL guidelines are the most influential hepatitis B guidelines in the Asia-Pacific region, which accounts for over 70% of the global hepatitis B burden. Inclusion in these guidelines:
- Validates TMF as a first-line treatment option for chronic hepatitis B
- Breaks the long-standing dominance of imported oral anti-HBV drugs (TDF, TAF, entecavir)
- Opens the door for TMF adoption in countries across Asia-Pacific
III. CSCO NSCLC Guidelines (2026): Ivonescimab Upgraded to I级推荐
The 2026 Chinese Society of Clinical Oncology (CSCO) Guidelines for Non-Small Cell Lung Cancer featured a significant update: ivonescimab (依沃西单抗注射液, brand: 依达方®), a PD-1/VEGF bispecific antibody developed by Akeso Biopharma (康方生物), was upgraded to I级推荐 (Class I Recommendation) for first-line treatment of PD-L1-positive NSCLC.
Key Details
| Aspect | Details |
|---|---|
| Drug | Ivonescimab (依沃西单抗, 依达方®) |
| Developer | Akeso Biopharma (康方生物) |
| Guideline | CSCO 2026 NSCLC Guidelines |
| Recommendation | I级推荐 for first-line PD-L1-positive NSCLC (squamous and non-squamous) |
| Significance | First PD-1/VEGF bispecific antibody to achieve Class I recommendation in NSCLC |
Clinical Evidence
The upgrade to Class I recommendation was supported by the Phase III HARMONi-2 study, which demonstrated:
- Significant PFS benefit over standard-of-care pembrolizumab in PD-L1-positive NSCLC
- Superior efficacy across both squamous and non-squamous histologies
- Manageable safety profile consistent with the mechanism of action
IV. CSCO Gastric Cancer Guidelines (2026): First CAR-T Included
The 2026 CSCO Gastric Cancer Guidelines included a landmark addition: satri-cel (舒瑞基奥仑赛注射液), the world's first CAR-T therapy for solid tumors, was included as a guideline annotation (指南注释) — marking the first time a CAR-T therapy has been included in CSCO gastric cancer guidelines.
Key Details
| Aspect | Details |
|---|---|
| Drug | Satri-cel (舒瑞基奥仑赛, Shurui®) |
| Developer | CARsgen Therapeutics (科济药业) |
| Guideline | CSCO 2026 Gastric Cancer Guidelines |
| Inclusion | Guideline annotation (指南注释) |
| Significance | First CAR-T therapy included in CSCO gastric cancer guidelines |
Why This Matters
The inclusion of a CAR-T therapy in gastric cancer guidelines — even as an annotation — represents a paradigm shift. It signals that:
- CAR-T has moved from "experimental" to "clinically recognized" in solid tumors
- Patients with advanced gastric cancer now have a guideline-supported cellular therapy option
- China is leading the global field in solid tumor CAR-T development
V. International Sepsis Guidelines (2026): Xuebijing Included
The 2026 International Guidelines for the Management of Sepsis and Septic Shock — jointly developed by the Surviving Sepsis Campaign (SSC) — included a Chinese traditional medicine for the first time: Xuebijing Injection (血必净注射液), developed by Chase Sun Pharmaceutical (红日药业).
Key Details
| Aspect | Details |
|---|---|
| Drug | Xuebijing Injection (血必净注射液) |
| Developer | Chase Sun Pharmaceutical (红日药业) |
| Guideline | SSC 2026 Sepsis Guidelines |
| Significance | First traditional Chinese medicine included in international sepsis guidelines |
Clinical Evidence
Xuebijing is a traditional Chinese medicine injection approved in China for sepsis. Its inclusion in the SSC guidelines was supported by:
- Multiple randomized controlled trials demonstrating reduced mortality in sepsis patients
- Systematic reviews and meta-analyses confirming its clinical benefit
- Favorable safety profile with no major safety concerns
This inclusion is historic as it marks the first time a traditional Chinese medicine has received recommendation in an international critical care guideline — a testament to the rigor of the clinical evidence supporting Xuebijing.
VI. Summary: Chinese Drugs in Global Guidelines – 2026 Snapshot
| Drug | Indication | Guideline | Recommendation Level |
|---|---|---|---|
| TMF (恒沐®) | Chronic hepatitis B | APASL 2026 | I级推荐 (Class I) |
| Ivonescimab (依沃西®) | PD-L1+ NSCLC (1L) | CSCO NSCLC 2026 | I级推荐 (Class I) |
| Satri-cel (舒瑞基奥仑赛) | Gastric cancer | CSCO Gastric 2026 | Guideline annotation |
| Xuebijing (血必净) | Sepsis | SSC 2026 | Recommendation |
VII. What This Means for International Patients
Inclusion of Chinese drugs in international and regional guidelines has direct implications for patients:
- Evidence-based confidence: Guidelines are based on rigorous evidence review. Patients can trust that these therapies meet the highest standards of clinical evidence.
- Global adoption: Guideline recommendations drive adoption worldwide. Chinese drugs recommended in APASL and CSCO guidelines are likely to be adopted in other countries as well.
- Access to first-in-class therapies: Some of these therapies — like satri-cel (first CAR-T for solid tumors) and ivonescimab (first PD-1/VEGF bispecific) — are available in China before other countries.
- Competitive pricing: Guideline-recommended Chinese therapies are often priced more competitively than their Western counterparts.
VIII. Conclusion: A New Standard of Recognition
The inclusion of Chinese innovative drugs in international and regional clinical guidelines in 2026 marks a new standard of recognition for Chinese biopharmaceutical innovation. From TMF in APASL guidelines to Xuebijing in SSC guidelines, Chinese drugs are now being recognized at the highest levels of evidence-based medicine.
This is not just a symbolic achievement. Guideline inclusion drives clinical adoption, improves patient access, and validates the quality of Chinese clinical research. It is the ultimate testament to China's transformation from a follower to a leader in drug development.
Chinese drugs have earned their place at the table of global clinical guidelines.