China developed diabetes drug highlights biopharma surge
The Efsubaglutide alfa injection pen.
Shanghai-based Innogen Pharma is set to shake up the diabetes treatment market with the approval of efsubaglutide alfa, a human-derived, long-acting GLP-1 receptor agonist aimed at adult type 2 diabetes.
This self-developed injection, branded Yinuoqing (怡诺轻), directly challenges the established dominance of Novo Nordisk and Eli Lilly, which have long led the space with top-selling drugs like semaglutide and tirzepatide.
The first prescriptions were issued last week at Shanghai Sixth People's Hospital and Nanjing Drum Tower Hospital, marking the official launch of this game-changing treatment. With this approval, Innogen becomes the third company globally – and the first in Asia – to secure independent intellectual property rights for human-derived, long-acting GLP-1 receptor agonist.
One of the first prescriptions was issued last week at Shanghai Sixth People's Hospital.
Efsubaglutide alfa stands out for its clinical superiority. Its extended half-life of 204 hours is significantly longer than semaglutide (168 hours), allowing for more convenient once or bi-weekly dosing.
In clinical trials, a 3mg dose reduced HbA1c by 1.1 percent in just four weeks and 2.2 percent after 24 weeks, demonstrating strong efficacy in blood sugar control. Non-diabetic participants also lost an average of 4kg (6.2 percent) in four weeks, with minimal gastrointestinal side effects and no serious hypoglycemia reported.
Combining safety, efficacy, and ease of use, efsubaglutide alfa is poised to disrupt the market, especially in China, where diabetes has reached epidemic proportions.
The growing GLP-1 RA market
The global diabetes crisis is escalating. By 2022, there were 828 million adults living with type 1 and type 2 diabetes worldwide, with China alone accounting for a staggering 148 million cases – 90 percent of which are type 2 and more than 60 percent linked to obesity, according to "The Lancet."
For decades, insulin has been the cornerstone of diabetes treatment. But the emergence of GLP-1 receptor agonists, which mimic the action of natural GLP-1 to regulate blood sugar, has revolutionized diabetes care. These treatments offer improved efficacy, safety, and a more favorable side effect profile compared to traditional insulin-based therapies.
The global GLP-1 receptor agonist market has exceeded US$50 billion by 2024, with human-derived treatments leading the way. For instance, Novo Nordisk's semaglutide generated a staggering US$29.3 billion in 2023, cementing its place as one of the top-selling drugs worldwide. By 2030, the total market is expected to surpass US$90 billion, positioning efsubaglutide alfa as a strong new contender in this rapidly expanding space.
Innogen's CEO, Wang Qinghua, called efsubaglutide alfa "best-in-class."
"We're not just targeting blood sugar," said Wang. "Efsubaglutide alfa acts as an intelligent regulator in the body, addressing both diabetes and obesity – two key metabolic issues that contribute to long-term health complications."
Generics to innovative drugs
The approval of efsubaglutide alfa highlights China's growing role as a biopharma powerhouse.
Over the past three decades, China's pharmaceutical industry has shifted from focusing primarily on raw materials and generics to innovative drugs. Reforms like the Marketing Authorization Holder (MAH) program have been key drivers in fostering domestic innovation and facilitating international licensing partnerships.
Between 2018 and 2024, China has launched 188 domestically developed innovative drugs – nearly double the number from the previous five years. This surge has positioned China as the second-largest global player in drug approvals, trailing only the US, according to the National Medical Products Administration (NMPA).
As China's biopharma sector continues to grow, homegrown drugs are increasingly gaining global recognition.
For example, BeiGene's cancer drugs, zanubrutinib and tislelizumab, have made significant strides in the US market. Zanubrutinib outperformed Johnson & Johnson's ibrutinib in clinical trials, contributing to a surge in BeiGene's revenue, from US$42 million in 2020 to US$1.29 billion in 2023, with over 70 percent of that coming from the US market. Similarly, Hutchmed's fruquintinib, approved by the US FDA in late 2023, is projected to exceed US$1.5 billion in global sales.
Innogen, with its growing global patent portfolio, is also accelerating expansion. Phase II trials for type 2 diabetes are underway in Australia, and Phase I trials for non-alcoholic fatty liver disease (NAFLD) in the US are set to begin soon.
Strategic licensing
China's expanding global presence is driven by its focus on international licensing deals, helping firms accelerate commercialization while mitigating risk. For instance, Hutchmed has partnered with Takeda for global approval of fruquintinib, while Junshi Biosciences collaborated with Coherus BioSciences to gain US FDA approval for toripalimab-tpzi.
According to Goldman Sachs, China's biotech sector is gaining global recognition, with Chinese firms now playing an important role in international expansion.
Investment bank Stifel projects that by 2024, one-third of licensing deals for large pharmaceutical companies involved Chinese firms – up from just 12 percent in 2022. Between Q1 and Q3 of 2024, Chinese companies secured 73 license-out deals, totaling US$33.6 billion in deal value, representing an 18-percent year-over-year increase, according to local pharm data platform Pharmcube.
The license-out model has proven effective for Chinese firms, enabling them to gain entry into major markets like the US and Europe while gaining valuable clinical trial experience and funding. As the global pharmaceutical landscape evolves, Chinese companies are reshaping the market by delivering comparable – or even superior – results at a lower cost.
However, challenges remain, particularly in building independent brands and controlling commercialization. But with companies like Innogen emerging as formidable competitors, China's influence on global pharmaceutical innovation is stronger than ever.
The question is no longer whether China will catch up to its global counterparts, but when it will take the lead.
