On February 25, 2025, the 2Firsts team visited Heno Biotech, a global leader in natural nicotine manufacturing, to gain insights into its compliance leadership and core drivers of scientific innovation. During the visit, Heno Biotech’s Chairman, Ze He, and senior executives engaged in discussions with the 2Firsts team, sharing how the company leverages technological innovation, compliance frameworks, and global market strategies to set industry standards and meet international regulatory requirements.
Global Market Strategy: Heno Biotech’s Path to International Compliance
In February 2025, Heno Biotech successfully completed its TPMF submission under the FDA’s PMTA framework, securing its TPMF Submission Tracking Number (STN) and receiving the FDA Acknowledge Letter.
This milestone allows Heno Biotech to officially authorize PMTA applicants to reference its TPMF. Notably, immediately after receiving the Acknowledge Letter, one of its downstream partners initiated discussions to incorporate Heno’s TPMF into their own regulatory applications. This rapid response underscores both Heno Biotech’s industry leadership in technology and compliance, as well as the trust its supply chain partners place in its regulatory expertise.
During discussions with 2Firsts, Chairman Ze He elaborated on Heno Biotech’s current progress, core strengths, and strategic outlook. In addition to its advancement in the novel tobacco sector, Heno Biotech has also secured the domestic pharmaceutical-grade natural nicotine production license in late 2024 and is on track to complete China’s National Medical Products Administration (NMPA) registration by August 2025. These efforts highlight Heno Biotech’s expansion from domestic compliance leadership to global regulatory integration, setting a benchmark for the nicotine industry worldwide.
Heno Biotech has long pursued a global expansion strategy, with growing recognition and market share in international markets. As global regulatory scrutiny intensifies, the company has accelerated its compliance efforts, securing market access in multiple jurisdictions to ensure its nicotine products align with diverse regulatory frameworks. The FDA TPMF approval not only signifies its formal entry into the U.S. compliance system but also lays the foundation for further expansion into additional international markets. Looking ahead, Heno Biotech aims to strengthen its presence in the U.S., Europe, and emerging markets, collaborating with global research institutions and regulatory bodies to establish a robust international compliance network.
2Firsts On-Site Visit: Inside Heno Biotech’s 5G Automated Factory and Compliance Monitoring System
Led by Vice President of Science and Technology Jiang Li, the 2Firsts team toured Heno Biotech’s newly built 5G fully automated digital factory and compliance monitoring system. By leveraging big data and artificial intelligence, the company has achieved full-process automation and digital management, covering raw material intake, production, packaging, and sales. This transformation has significantly improved production efficiency and quality control.
Heno Biotech has the ability to process over 60,000 tons of tobacco waste annually and produce more than 600 tons of high-purity nicotine (99.9% purity), positioning itself as a leading supplier of core raw materials for the novel tobacco industry in China.
Beyond its advanced production processes, Heno Biotech is at the forefront of safety, compliance, environmental responsibility, and regulatory traceability. The company serves as a model enterprise for numerous industry and national standards, pioneering regulatory frameworks in nicotine manufacturing.
Competing in the Global Market: How Heno Biotech Stays Ahead
Heno Biotech not only focuses on its own compliance efforts but also actively collaborates with leading global enterprises. The company prioritizes partnerships with compliance-oriented international tobacco companies and long-term, regulation-focused enterprises in both domestic and international markets. By fostering cooperation with downstream companies that share a commitment to compliance and sustainable development, Heno Biotech supports advancements in R&D, scientific research, product innovation, and market expansion, ensuring a healthier and more sustainable industry trajectory.
2Firsts learned that Heno Biotech’s international footprint dates back to the early days of open-system vaping products, when the company gained global recognition. Through multiple waves of industry transformation and product category upgrades, Heno Biotech has solidified its role as a core raw material manufacturer within the global nicotine supply chain. Now, it is actively constructing a new competitive landscape in the industry, aiming to establish a stable supply chain and compliance system across multiple key markets. In addition to advancing its U.S. PMTA process, the company is also pursuing regulatory approvals in Europe, Asia, and other strategic regions, working closely with local research and regulatory institutions to ensure product compliance with regional safety and quality standards.
Chairman Ze He stated, “We are not just striving to be the most advanced compliance-driven enterprise, but also to play a pivotal role in driving industry-wide regulatory progress and technological innovation.” Moving forward, Heno Biotech will intensify its global expansion, strengthen partnerships with compliance-focused downstream enterprises, and contribute to a more transparent and sustainable industry landscape, ultimately providing safer and higher-quality nicotine alternatives for global consumers.
Natural Nicotine’s Compliance Advantage Amid Global Regulatory Shifts
The rise of synthetic nicotine as a regulatory workaround has sparked widespread debate in the novel tobacco industry. While some manufacturers claim synthetic nicotine is purer and easier to regulate, scientific evidence has yet to conclusively prove that it offers safety or quality advantages over natural nicotine.
According to Labstat and other leading analytical laboratories, natural nicotine has demonstrated greater compliance stability amid increasingly stringent global regulations. Research indicates that natural nicotine consists almost entirely of S-nicotine, while synthetic nicotine often contains a higher proportion of R-nicotine. Due to limited toxicological and long-term health impact studies on R-nicotine, many regulatory bodies remain cautious. As a result, using natural nicotine reduces regulatory risks while ensuring consistent bioavailability and consumer experience. This shift has reinforced the compliance advantages of natural nicotine, which offers traceable sourcing and clear regulatory pathways.
As a leading natural nicotine manufacturer, Heno Biotech is committed to promoting the global development of natural nicotine through advancements in technological innovation, regulatory standards, scientific research, and market expansion. The company focuses on refining extraction techniques and implementing stringent quality control measures to enhance purity, stability, and traceability, ensuring compliance with key international regulatory frameworks.
Additionally, Heno Biotech collaborates with global research institutions, regulatory bodies, and industry leaders to develop improved safety assessment frameworks for natural nicotine and facilitate its adoption in a wide range of novel tobacco products. The company plans to expand its efforts in product innovation, market entry, and sustainable supply chains, further supporting the global harm reduction movement.
2Firsts: A Key Partner in Compliance and Innovation
During the visit, 2Firsts gained a deep understanding of Heno Biotech’s corporate culture, where compliance and innovation are fundamental values. The company has demonstrated a long-term commitment to compliance, technological research, and large-scale industrial applications of natural nicotine, providing a valuable model for the industry.
2Firsts will continue leveraging its platform, industry expertise, and research capabilities to explore further areas of collaboration with Heno Biotech, assisting companies in navigating globalization challenges and identifying new growth opportunities. Additionally, 2Firsts will open more in-depth site visits and discussions to provide industry stakeholders with cutting-edge insights and partnership opportunities.
Outlook: Driving Global Compliance and Sustainable Development
This in-depth visit not only strengthened the collaboration between 2Firsts and Heno Biotech but also provided valuable insights into the sustainable development of the novel tobacco industry. As Heno Biotech continues its global expansion and advances natural nicotine innovation, the industry is expected to witness higher standards, safer compliance measures, and a more robust ecosystem.
2Firsts remains committed to supporting companies through expert insights, compliance intelligence, and market expansion strategies. This research initiative is open to industry participants, and 2Firsts invites more companies to join the conversation on industry development, technological innovation, and regulatory collaboration. Interested parties can reach out via info@2firsts.com or connect with 2Firsts CEO Alan Zhao on LinkedIn.
