China's Sunshine Lake Pharma has won US Food and Drug Administration approval for its insulin glargine injection, marking the first time a Chinese-developed insulin has obtained the regulator's "interchangeable biosimilar" designation — a milestone that underscores the accelerated entry of Chinese biopharmaceutical companies into high-end global markets.

The label allows pharmacists in the United States to substitute the drug for Lantus — a long-acting insulin originally developed by France's Sanofi — without requiring a new prescription, a regulatory status considered the highest standard for biosimilars and a key advantage in the US market.

Marketed as Langlara, the once-daily administered insulin is approved for adults and children with Type 1 diabetes and for adults with Type 2 diabetes, the Hong Kong-listed company said in a filing to the Hong Kong bourse on Monday.

The approval was supported by a Phase I glucose clamp study involving 104 subjects, which demonstrated pharmacokinetics and pharmacodynamics comparable to Lantus in healthy volunteers. The decision followed an FDA inspection of the company's manufacturing facilities, conducted between September and October 2025, according to the filing.

With the clearance, Langlara becomes the fourth insulin glargine product available in the US market and the first from a Chinese company, marking not only a milestone in Sunshine Lake Pharma's international expansion, but also a broader shift in China's pharmaceutical industry as domestic firms begin to compete in regulated, high-value global markets.

Chinese biopharma has rapidly expanded its global footprint in recent years. Data from the National Medical Products Administration showed that the cross-border out-licensing deals of Chinese biotech firms hit a record transaction value of $60 billion in the first quarter, reflecting growing recognition of China's innovation pipeline.

The figure represents a 73 percent increase year-on-year and already amounts to nearly half of the total $135.7 billion worth of agreements signed in full-year 2025.

Foreign pharmaceutical companies including AstraZeneca, Novartis and Pfizer have increasingly partnered with Chinese firms to access new therapies, particularly in areas such as antibody-drug conjugates and next-generation biologics.

In addition, over the past few years, an increasing number of Chinese biotech firms have moved beyond licensing deals and begun advancing self-developed products into late-stage clinical trials and regulatory submissions in the US and Europe, signaling a growing trend of direct market entry rather than "out-licensing".

To commercialize Langlara in the US, the company has partnered with US-based Lannett to sell the products in the country, granting it exclusive distribution rights for insulin glargine and insulin aspart. An initial order of at least 18 million units over 18 months has already been secured, the company said.

Founded in 1942, Lannett distributes medicines through wholesalers, retail pharmacy chains and hospital channels across the US.

According to market research firm QYResearch, the global market for insulin glargine is estimated to be close to $10 billion, with the US accounting for more than 60 percent of global sales.

The US insulin glargine market has long been dominated by Sanofi, alongside biosimilars from companies including Eli Lilly and Biocon.

The entry of a Chinese interchangeable biosimilar is expected to intensify price competition while also testing the ability of Chinese manufacturers to meet the regulatory and commercial requirements of the US market.

The approval also comes as several Chinese insulin manufacturers accelerate efforts to enter the US market. Tonghua Dongbao Pharmaceutical said its insulin aspart biologics license application has been accepted for review by the FDA, while Gan & Lee Pharmaceuticals has submitted an application for insulin lispro that is currently under substantive review.