Tariff changes reshape the logic of going global. Can the biopharmaceutical industry usher in development opportunities?

Since the significant easing of Sino-US relations on May 12 and the substantial reduction in trade tariffs, the new window of opportunity for Chinese pharmaceutical companies to explore the US market has attracted much attention. Trump's statement about significantly lowering US drug prices has further stirred the global pharmaceutical industry landscape. Against this backdrop, how some biopharmaceutical companies with leading technologies and targets will develop their overseas expansion strategies and benefit from the improved Sino-US trade environment has become a hot topic of discussion.

Tariff adjustments open a new window for pharmaceutical exports

On May 12, 2025, China and the US jointly issued the "Sino-US Geneva Joint Statement on Economic and Trade Talks" in Geneva, Switzerland, announcing a substantial reduction in bilateral tariff levels. According to the statement, the US canceled 91% of the additional tariffs, retaining only 10%; another 24% of tariffs were suspended for 90 days. China simultaneously canceled 91% of its retaliatory tariffs, also retaining 10%, and suspended the implementation of 24% of tariffs.

This tariff adjustment provides a rare window of opportunity for Chinese pharmaceutical companies to expand overseas. The cancellation of 91% of tariffs will significantly reduce the cost of exporting Chinese pharmaceutical products to the US. Categories with cost and production advantages, such as GLP-1, biosimilars, and active pharmaceutical ingredients (APIs), are expected to rapidly increase their market share in the US. Especially against the backdrop of Trump's push to relax FDA reviews and expand drug imports, the "full industrial chain" capabilities of Chinese pharmaceutical companies stand out even more.

At the same time, Trump's high-profile statement on May 11 that US drug prices would be aligned with those of the countries with the lowest drug prices globally, potentially reducing prescription and drug prices by 30% to 80%, has sent shockwaves through the global pharmaceutical industry. For a long time, the FDA has maintained a commercial 闭环 through high drug prices, and Trump's drug price policy may disrupt this 格局， creating new market opportunities for Chinese innovative pharmaceutical companies.

In this context, some companies are particularly noteworthy. For example, $HUA MEDICINE-B(02552.HK), a representative company in the domestic oral hypoglycemic drug field with the world's first-in-class drug glucose 激酶 activator (GKA) 华堂宁® (dorzagliatin), has already achieved impressive 业绩 in the domestic market and is now entering a critical period for overseas expansion. Pacific Securities pointed out in its latest company research report that given the extensive clinical and real-world efficacy evidence for 华堂宁®, coupled with the lack of new-mechanism oral hypoglycemic drugs in overseas markets, it is optimistic about the BD prospects of the second-generation GKA, an upgraded version of 华堂宁® that has already begun clinical trials in the US.

Financially，华领医药's capital strength supports its R&D and internationalization strategies. Data shows that it had 1.14 billion yuan in cash at the end of 2024, with 预计 cash reserves sufficient to maintain normal daily operations until 2027. This provides ample time to advance product development and market expansion.

华领医药: From domestic to international

华领医药's products and R&D capabilities have already been tested in the domestic market. Last year, its annual sales revenue reached 255.9 million yuan, a 234% increase compared to 2023; other income was approximately 116.8 million yuan.

2024 was the first full year 华堂宁® was included in the national 医保目录， and the 医保放量 effect was very 明显， driving significant revenue growth for the company. During the year，华堂宁® covered about 2,700 hospitals nationwide, with the user base growing from 20,000 at the end of 2023 to over 150,000 by the end of 2024. Annual sales volume reached 2.105 million boxes, a 740% increase compared to 2023.

As the world's first GKA，华堂宁® differs significantly in mechanism from existing hypoglycemic drugs such as DPP-4, SGLT-2, and GLP-1. It targets glucose sensors, aiming to regulate 血糖稳态 and treat diabetes at its source, with outstanding efficacy and safety, helping patients 重塑受损的血糖稳态功能. After entering the 医保，华堂宁®'s price is also highly competitive, at just 5.39 yuan per 75mg tablet.

Earlier this year，华领医药 further strengthened its sales team by hiring executives with experience in 糖尿病 teams at Eli Lilly and Novo Nordisk. In the first two months of 2025，华堂宁® sales reached 592,000 boxes, with net sales of approximately 73.2 million yuan, a 199% year-on-year increase.

At a previous earnings conference, the company's management disclosed plans to expand the sales team to over 100 people by April this year, focusing on economically 发达 cities while 辐射 other non-core areas. Now, against the backdrop of Sino-US tariff adjustments，华领医药's international opportunities have also opened up.

It is reported that 华堂宁® has begun preparations for registration in Macau and Hong Kong, with applications expected to be submitted this year, paving the way for entry into the Southeast Asian market. However, the real key is the US, the world's largest pharmaceutical market.

For the US market，华领医药 is focusing on advancing its second-generation GKA drug. This drug has already completed Phase 1a clinical studies in the US and is an "upgraded version" of 华堂宁®, requiring only once-daily oral administration (华堂宁® requires twice daily). Since 华堂宁® is the only 原研 GKA drug targeting this mechanism globally, competition is virtually nonexistent, giving 华领医药 a significant advantage with its 超前布局。

Pacific Securities noted in its report that the company completed Phase 1a clinical SAD data readout for the second-generation GKA in the US in November 2024, showing that the drug 几乎完全转化为多格列艾汀 in vivo and supports QD 给药. Phase 1b studies in the US are expected to begin in 2025.

At the previous earnings conference，华领医药 stated that the second-generation GKA 更关注西方 2 型糖尿病患者的特点， who often have 肥胖症状. Studies have shown that 华堂宁® can promote GLP-1 secretion and improve insulin sensitivity, potentially bringing new benefits to this patient 群体. With 38.2 million 处方-treated 2 型糖尿病患者 in the US, new treatment options could carve out a significant share of the existing market.

Conclusion: Seizing the window for pharmaceutical 出海

The 叠加 of tariff adjustments and US drug price policy changes is creating unprecedented opportunities for Chinese innovative pharmaceutical companies to enter the international market. With its globally unique GKA 靶点 products，稳健的 domestic market expansion, and clear internationalization strategy，华领医药 is well-positioned to take the lead in this wave of pharmaceutical industry 变革。

As Pacific Securities noted，华领医药 combines 顺利 domestic commercialization，稳步推进 internationalization, and 充足 cash reserves，有望 achieving profitability by 2027.

For investors 关注 Chinese innovative pharmaceutical 出海 opportunities，华领医药 is undoubtedly a company worth watching closely. The improving macroenvironment will accelerate 出海， propelling this 糖尿病治疗 innovator onto a broader international stage.

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