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[Hongke Insights] Innovative Drugs in China: Without Expanding into Overseas Markets, They Face Elimination

In China’s innovative drug industry in 2025, there is a half-joking yet brutally honest adage: “If you don’t expand into overseas markets, you’ll be left behind.”

These twelve words, which were merely a warning a few years ago, have now become the industry consensus. As price cuts in mainland China’s health insurance negotiations grow increasingly steep and the consistency evaluation of generic drugs continues to squeeze the profit margins of “me-too” products, a large number of biotech startups have discovered that relying solely on the mainland market is simply insufficient to sustain their operations. Expanding overseas is no longer a matter of choice, but a matter of survival—one that determines the very existence of these companies.

I. From the Lab to the Global Market: China’s Innovative Drugs Shift into “High Gear”

In 2025, China’s innovative drugs delivered impressive results in overseas markets. According to statistics from a specialized pharmaceutical database, the total value of out-licensing transactions for Chinese innovative drugs in overseas markets reached $135.655 billion in 2025, representing a year-over-year increase of approximately 161%. Even more noteworthy is that the transaction value of China’s innovative drugs accounted for 49% of the global total, surpassing the United States for the first time.

As we enter 2026, this wave of overseas expansion shows no signs of slowing down. In the first quarter alone, the total value of outbound business development (BD) deals for innovative Chinese drugs exceeded $60 billion. This means that the transaction volume for the first three months of 2026 was already nearly half of the total for the entire year of 2024.

Statistics from Chinese regulatory authorities also confirm this trend. Data from the National Medical Products Administration show that in the first quarter of 2026, the total value of business development (BD) transactions for innovative drugs in China successfully surpassed $60 billion.

From “selling products” to “exporting technology,” and from “passive licensing” to “proactive strategic positioning,” China’s innovative drugs are shedding their former role as followers and have officially taken center stage in the global arena of innovative pharmaceuticals.

II. Turning a Loss into a Profit Through Global Product Expansion: How BeiGene Transformed Itself into a Global Biopharma Giant

If macroeconomic data provides a panoramic view, then the case of BeiGene offers a close-up. In 2025, BeiGene’s annual revenue reached 382.05 billion yuan, representing year-over-year growth of more than 40%. More importantly, this marks the first time in the company’s 16-year history that it has turned a full-year profit, with net income attributable to the parent company reaching 1.422 billion yuan.

The driving force behind these impressive results is BeiGene’s in-house developed BTK inhibitor—Zebutini (Baiyueze). In 2025, global sales of zebutinib reached 280.67亿元人民币, representing a year-over-year increase of 48.8%. The U.S. market contributed the majority of this revenue, with a year-over-year growth rate of 45%. Currently, Zebrutinib has been approved for marketing in more than 75 markets worldwide, covering multiple indications such as chronic lymphocytic leukemia.

Even more striking is the proportion of overseas revenue generated by Zebrutinib. More than 90% of this product’s revenue comes from overseas markets. In other words, it was precisely through expanding into overseas markets that BeiGene transformed from a biotech company reliant on external funding into a global biopharma giant with stable, self-sustaining revenue generation capabilities.

The story of BeiGene is, in fact, a microcosm of the broader wave of Chinese innovative drug companies expanding into the global market. As more and more biotech companies realize that globalization is the true ceiling for their growth, going global is no longer just an adventure for a handful of pioneers, but a collective endeavor for the entire industry.

III. The Compliance Hurdles Behind the Glitz The real test begins the moment the drug leaves the factory

Once a consensus is reached on expanding into overseas markets, innovative pharmaceutical companies are faced with a series of very practical challenges.

Obtaining approval from the U.S. FDA or having an application accepted by the European EMA is merely the first step in a long journey. The real challenge begins the moment the drug leaves the factory gates—how can you ensure that your drug remains within the specified temperature range and arrives intact in the hands of overseas patients after traveling thousands of kilometers and undergoing multiple transshipments and storage operations?

Biologics are far more temperature-sensitive than most people realize. According to the technical requirements of the FDA and the World Health Organization (WHO), most biologics must be stored and transported in a cold chain environment at temperatures between 2°C and 8°C; certain vaccines and biological samples require ultra-low-temperature conditions ranging from -20°C to -70°C; and cell and gene therapy (CGT) products must be carefully preserved throughout the entire process in liquid nitrogen at temperatures below -150°C.

At the same time, major global drug regulatory agencies are imposing increasingly stringent scrutiny on temperature data. The U.S. FDA’s 21 CFR Part 11 explicitly stipulates that electronic temperature records used to support GMP decisions must possess the same level of data integrity and audit trail capabilities as paper records. Similarly, the EU GDP guidelines require that temperature monitoring equipment be properly maintained during transport and calibrated at least once a year. Any missing temperature records at any stage could constitute a critical deficiency during a regulatory audit.

For innovative pharmaceutical companies looking to expand into overseas markets, selecting a temperature monitoring solution that is recognized by global airlines, accepted by overseas regulatory agencies, and readily accepted by overseas recipients without any barriers is not only a technical guarantee of product quality but also a critical step in determining whether the product can successfully enter the target market.

IV. Hongke ELPRO Temperature Monitoring Solution Making Temperature Records a Globally Recognized Compliance Passport

Hongke’s ELPRO LIBERO C Series is the world’s first brand to introduce temperature data loggers that generate reports in PDF format. These reports are fully compliant with the PDF/A standard (ISO 19005-1), providing comprehensive support to help users meet stringent global regulatory requirements such as GMP, GLP, and FDA 21 CFR Part 11.

Hongke LIBERO Series Temperature Loggers

To address the cold chain compliance needs of Chinese pharmaceutical companies expanding into overseas markets, the LIBERO series offers the following key solutions:

  • Air Transport Compliance: Verifiable with Documentation: The Hongke LIBERO series has received dual certification—the “Certificate of Compliance with Conditions of Carriage” from the Shanghai Research Institute of Chemical Industry and the “Air Transport Conditions Assessment Report” from Beijing DGM—and fully complies with the exceptions for functional equipment outlined in the International Air Transport Association (IATA) Dangerous Goods Regulations. Currently, more than 40 major airlines worldwide have included it on their approved lists. This means that the temperature monitoring equipment itself will not pose an obstacle during air cargo security screening, and pharmaceutical companies and freight forwarders do not need to prepare additional dangerous goods declaration documents for this purpose. (Reference Documents: Beijing DGM Dijiem Aviation Transport Hazard Identification Report / Shanghai Institute of Chemical Industry Transport Hazard Assessment Report)

  • Plug-and-play, no additional training required: The Hongke LIBERO series is the first-of-its-kind PDF temperature logger; the PDF reports it generates can be automatically converted into tamper-proof PDF temperature data reports simply by plugging the device into any computer’s USB port. Recipients anywhere in the world do not need to install specific software, purchase a card reader, or undergo operational training. For scenarios involving multiple receiving locations—such as international multicenter clinical trials (MRCTs) and drug exports—this “zero-barrier” design significantly reduces the probability of human error at the operational level.

  • Compliant Data, Globally Recognized: The PDF reports generated by the Hongke LIBERO series are non-editable, fully meeting the FDA’s requirements for electronic records while helping users comply with major pharmaceutical supply chain regulations such as GSP, GMP, GDP, and WHO standards. From Pfizer to Novo Nordisk, and from GSK to Bayer, many of the world’s top 50 pharmaceutical companies are long-standing customers of ELPRO—a fact that serves as the most direct and compelling validation of its compliance capabilities.

  • Single-use, extremely cost-effective (great value for the price): In export shipping scenarios, temperature loggers typically do not need to be returned, so a single-use solution is the most efficient option. Hongke’s ELPRO LIBERO CB eliminates the need for return management processes and cross-border logistics costs, resulting in a significantly lower cost per use compared to solutions that require multiple returns. A single model supports multiple temperature configurations, reducing the number of SKUs in inventory and further alleviating procurement and warehousing pressures.

Conclusion

Returning to the opening statement: Without expanding into overseas markets, we face elimination. But entering the international market is by no means just a slogan. It means that every step—from R&D to production, from warehousing to distribution, and from Chinese factories to overseas patients—must be re-examined and refined in accordance with global compliance standards.

When our innovative drugs travel thousands of kilometers to reach overseas markets, the temperature data that ensures their quality compliance must withstand scrutiny from the world’s most stringent regulatory agencies. On this path to globalization, cold chain compliance is not an optional extra—it is an essential prerequisite. Failure to expand into overseas markets means facing elimination; but if you’re ready to enter the global market, be sure to bring along Hongke ELPRO’s temperature compliance assurance.

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