TongXieYi: Steidutumab was approved for marketing in February 2025 and was successfully included in the National Reimbursement Drug List (NRDL) within the same year, an exceptionally fast process. What strategic commitment does this reflect on the part of the company? For an innovative biotechnology company, why is "rapid reimbursement access" considered the highest-priority and most essential goal after product launch?

Zhao Wengui: From the perspective of our corporate mission and values, "creating clinical value" is the mission of Trinomab, while "respecting life and prioritizing patients" is one of our core values. Steidutumab, as a global first-in-class (FIC) product, embodies this philosophy in practice:

Clinical studies have confirmed that it significantly improves the safety and completeness of protection in tetanus passive immunization. From the standpoint of clinical needs, it is conservatively estimated that 40–50 million people in China require tetanus passive immunization annually due to trauma. Tetanus itself is a disease whose risk of onset must be prevented through "therapeutic prevention."

The successful inclusion of Steidutumab in the NRDL, supported by national reimbursement policies, enhances its safety, accessibility, and priority for clinical use in emergency tetanus prevention scenarios. The primary need of trauma patients is immediate intervention and urgent prevention of tetanus onset. This product was developed precisely to address this core need.

In terms of commercialization efficiency and cash flow enhancement, innovative drug development is characterized by high investment, long cycles, and significant risks. As Trinomab’s first approved product after "a decade of meticulous effort," the commercialization process of Steidutumab is critical to the company’s development.

Currently, several innovative products in the company’s pipeline are progressing in R&D. The realization of the social value of Steidutumab will directly alleviate the financial pressure of subsequent R&D efforts. Meanwhile, the inclusion of Steidutumab in the NRDL not only reduces the financial burden on patients but also facilitates bridging the "last mile" from approval to clinical application, thereby enhancing commercialization efficiency.

TongXieYi: I also noted a detail: in addition to the NRDL, Steidutumab was also applied for inclusion in the commercial health insurance list, making it one of the 79 products that passed the formal review stage for both reimbursement lists. This underscores our determination to secure reimbursement coverage. What considerations were behind the decision to apply for both lists simultaneously?

Zhao Wengui: Tetanus prevention is a form of therapeutic prevention, and trauma scenarios vary widely. Individuals with active social lives and employees of medium to large enterprises often have commercial insurance as part of their benefits package, purchased uniformly by their employers. When trauma necessitates tetanus passive immunization, commercial insurance typically covers the cost. However, there are also many scenarios—such as injuries caused by third-party liability or animal bites—where patients usually pay out of pocket for medical expenses. Given the nature of the product, even with inclusion in the NRDL, these diverse payment scenarios will persist.

In the context of advancements in commercial health insurance in 2025, applying for inclusion in both lists would better serve the public and protect patients across different scenarios. It would also facilitate the government’s efforts to integrate resources and explore practical approaches. From the perspective of patients’ complete decision-making process regarding payment, this is not merely a choice between insurance coverage and out-of-pocket payment but a comprehensive consideration of willingness to pay, risk awareness, and medical convenience.

Building a diversified payment system aims to cover patient groups with varying payment capacities and levels of awareness, ensuring that payment does not become a barrier to accessing the best treatment options in urgent prevention scenarios. Although no products achieved dual-listing in 2025, the ongoing development of multi-level healthcare security and policy support remains worthy of further practice and reflection.

TongXieYi: To ensure market expansion after reimbursement inclusion, what specific plans and goals does the company have regarding sales team development, hospital access, channel coverage, and coordination between the internal sales team and external promotion partners?

Zhao Wengui: The company has established a self-operated commercial team of over 400 professionals, primarily focused on promoting the product in leading academic and influential second- and third-tier hospitals. Simultaneously, we engage external promotion partners to gradually participate in post-reimbursement product access and market expansion.

The in-house team and external partners collaborate closely, integrating resources to advance brand building and product access coverage. This synergy fosters a win-win cooperation, jointly striving for better solutions in a field where innovative advancements are possible and where current tetanus prevention methods present numerous challenges for both medical professionals and patients.

In terms of specific clinical promotion strategies, we adhere to the scientific principle and practical treatment pathway of "prioritizing emergency prevention." For trauma patients at risk of tetanus, the first and essential step is immediate assessment and, if necessary, passive immunization (emergency prevention). The Expert Consensus on the Application of Passive Immunization Agents for Post-Tetanus Exposure Prophylaxis also designates the anti-tetanus monoclonal antibody (Steidutumab) as the preferred choice for post-trauma passive immunization.

After completing emergency prevention, patients can be advised to receive tetanus vaccination for long-term protection according to guidelines. This scientifically grounded concept of integrating medical treatment and prevention can, to some extent, avoid inappropriate prescription or misuse of passive immunization agents while preventing overstatement of vaccine efficacy and patient psychological resistance to decision-making.

This promotion logic—"address urgent risks first, then plan for long-term protection"—aligns with clinical reality, is more easily understood and accepted by both medical professionals and patients, and helps rapidly establish the product as the preferred choice for disease prevention and treatment.

TongXieYi: Beyond the National Reimbursement Drug List (NRDL), is the company exploring other payment channels, such as commercial health insurance, local inclusive insurance programs, and non-hospital markets, to enhance patient accessibility?

Zhao Wengui: In alignment with the policy’s original intent, we are committed to building a multi-level, three-dimensional payment security network to collaboratively ensure that innovative drugs are "accessible" and "affordable."

In April 2025, Steidutumab Injection was successfully included in Zhuhai’s supplemental medical insurance project, "Boundless Love," allowing enrolled patients in Zhuhai to receive a 70% reimbursement.

Subsequently, Steidutumab Injection was incorporated into Guangzhou’s "Sui Xin Bao · Pearl River Drug Safety"—the first commercial health insurance in China covering "Hong Kong and Macao Drug and Device Access" and high-value innovative drugs and devices. Under this program, eligible patients enjoy 100% reimbursement with no deductible, achieving a breakthrough in "zero out-of-pocket expense."

From securing provincial-level innovative drug catalog recognition to building a multi-level security network encompassing local inclusive insurance, innovative commercial insurance, and national payment platforms, each step aims to harness the collective strength of policies, insurance, and ecosystem platforms. The ultimate goal is to ensure that Steidutumab Injection, as a global first-in-class product, delivers a safer and more effective solution for tetanus prevention and treatment.

TongXieYi: Tetanus prevention is in high demand at primary healthcare institutions. What specific strategies does the company have to promote the product’s adoption in county-level hospitals, community health centers, and even township health clinics? Will innovative channel collaboration models be adopted?

Zhao Wengui: The need for emergency tetanus prevention is widespread in primary healthcare settings. In grassroots promotion, we will emphasize the convenience and safety of the solution. The features of "no skin test required, one injection suffices" perfectly align with the needs of primary healthcare institutions, which often have limited resources and prioritize simplicity and safety.

We will actively empower primary healthcare institutions by assisting them in establishing clear, standardized, and actionable protocols for tetanus trauma management, comprehensively enhancing their capacity for tetanus prevention and treatment. For example:

• Rapid wound assessment and cleaning.

• Emergency prevention with the consensus-recommended anti-tetanus monoclonal antibody (Steidutumab) as the preferred choice.

• Referral or vaccination as needed.

Through this approach, patients no longer need to miss the optimal prevention window due to waiting for skin test results or fearing allergic reactions. Instead, they can receive high-standard protection immediately.

TongXieYi: What is the milestone significance of Steidutumab's successful inclusion in the National Reimbursement Drug List (NRDL) for Trinomab as an innovative biotechnology company? How will this impact the R&D and commercialization strategies of the company's subsequent pipeline?

Zhao Wengui:
(1) Reinforcing High-Quality and Original Innovation:
The synergy between reimbursement policies and clinical application creates a demonstration effect, aligning with the national theme of "supporting genuine innovation and differentiated innovation," thereby reducing excessive internal competition. At the same time, the company actively explores and practices the construction of a multi-level healthcare security system.

(2) Strengthening the Implementation of Corporate Mission and Values:
For patients, the shift from out-of-pocket payment to insurance coverage ensures that life-saving protection is within reach. Among tetanus patients, 10% have an incubation period of less than 48 hours, some even shorter than 24 hours, making the prevention window extremely narrow. Reimbursement coverage ensures that patients can confidently choose the globally leading "optimal solution" in emergencies, avoiding delays in the best prevention window due to payment concerns.

(3) Advancing Equitable Access to Grassroots Healthcare:
After its inclusion in the NRDL, Steidutumab’s features of "no skin test required, one injection suffices" will significantly optimize emergency procedures and alleviate pressure on medical resources. The drug not only reduces medication risks and eliminates the skin test process, simplifying workflows for healthcare professionals, but also elevates the overall clinical standard for tetanus prevention and treatment. By extending its reach to grassroots medical institutions, it will greatly enhance tetanus prevention capabilities nationwide, narrowing regional healthcare disparities and transforming innovative achievements from "available" to "accessible."

Trinomab's R&D pipeline and commercialization strategy, as reflected in the milestone significance of Steidutumab, will focus on integrating product innovation, value translation, and disease prevention capabilities. Through target validation and experience accumulation, we aim to strengthen Trinomab's competitive advantage in the high-throughput natural fully human monoclonal antibody drug development field and fulfill our social responsibility.

TongXieYi: Based on market expectations for Steidutumab, what are the company's internal plans for its sales targets and market share over the next 1–3 years? Looking further ahead, what changes do you hope this product will bring to China's tetanus prevention landscape?

Zhao Wengui:
The launch of Steidutumab Injection is expected to profoundly reshape China's tetanus prevention landscape across three dimensions: clinical standards, public health, and disease awareness.

The goal for the next 1-3 years is to establish China's leading brand and first-choice recommended medication for tetanus prevention and treatment. Through continuous market promotion and increased public awareness, the aim is to achieve market coverage across major tiered hospitals and gradually expand into county-level and broader grassroots markets. This will position the product as a strong alternative to HTIG in meeting unmet market demands, while also providing a timely substitute for TAT in grassroots regions with better economic conditions and payment capabilities, especially for patients with allergic reactions to TAT.

Xie Yi Jun: How do you view the current trend towards multi-level and diversified payment mechanisms for innovative drugs? From the perspective of the enterprises themselves, in which key areas do you think further collaboration and innovation are needed to better promote the accessibility of innovative drugs?

Zhao Wengui: The current national shift towards multi-level and diversified payment mechanisms represents a historic opportunity to transform the value realization of innovative drugs from a singular "price game" to a comprehensive "system competition." To truly seize this opportunity, I believe enterprises need to strengthen synergistic alignment with national policies in the following four areas:

(1) Value Synergy: It is necessary to construct diverse value evidence and develop a "value package" tailored for payers, incorporating pharmacoeconomic data and evidence of medical resource savings.

(2) Implementation Synergy: The integration of medical insurance, commercial insurance, hospital access, and patient services should be prioritized to establish a closed-loop system of "access-prescription-payment."

(3) Data Synergy: Proactively collaborate with payment platforms and medical institutions to build a data ecosystem, utilizing real-world evidence to drive the effectiveness and sustainability of payment solutions.

(4) Policy Synergy: Establish proactive mechanisms for policy analysis and learning, swiftly transforming regional breakthroughs into replicable standardized models.