Chinese biotech companies hit inflection point on way to world prominence

Shanghai-based Henlius Biotech, a leading Chinese biopharmaceutical company, announced on April 15 that it will launch eight new products globally in the next four years, begin sales of its first product in Japan in 2027 and aim to become a top 20 company in Japan, the world's third-largest pharmaceutical company in the coming decade.

Its March earnings report profit for a second year running as 2024 revenue rose 6.1 percent to 5.72 billion yuan (US$782.7 million). While that may still fall short of leading multinationals like Pfizer, Novartis, Amgen and Gilead, Henlius and other China biotech companies sit at a pivotal point this year on their way to becoming a strong force in global pharmaceuticals.

There are four emerging powerhouses in China biotech: Henlius, BeiGene, Innovent and ZaiLab. All were founded in the 2010s, when China became a lucrative market for biotech companies because of its large consumer base and streamlined regulatory approval process for innovative medicines.

Henlius was set up in 2010, BeiGene and Innovent in 2011, and ZaiLab in 2014. In the ensuing years, they start to break even and establish solid global outreach. Henlius is one of only a few Chinese biotech companies covering all five continents, with its own team on the ground or through local partners.

Beigene, which has headquarters in the US, China and Switzerland and recently changed its listing name to BeOne, posted global revenue of US$3.8 billion in 2024.

"Our full-year results demonstrate our tremendous growth as a global oncology powerhouse," said John V Oyler, the company's co-founder and chief executive officer, who noted that 2025 will mark an inflection point for the company's bottom line.

HK-listed Innovent Biologics, based in Suzhou, said revenue last year grew 8 percent to 421.9 million yuan, with the aim of achieving annual sales of 20 billion yuan in 2027.

Shanghai-based ZaiLab, listed on both Nasdaq and Hong Kong exchanges, was founded by Samantha Du, an entrepreneur sometimes called the "godmother of China's biotech industry."

The company reported 2024 revenue surged 50 percent from a year earlier to US$399 million and said it aims to reach net profitability in the last quarter of this year and sales of US$2 billion by 2028.

These biotech companies are among the first to break even or reach that point in 2025. But their winning formulas are similar – steady sales growth both at home and abroad, development of a robust drug candidate pipeline, establishment of their own supply chains, an expanded global footprint and enhanced cooperation with the world's leading institutions and scientists. All achievements could hardly have been predicted for Chinese biotech companies just 10 years ago.

Henlius has launched six products in the China market and four products in overseas markets, with more than 750,000 patients benefiting from their medicines globally.

The company's core product for breast cancer, called Hanquyou, has enjoyed robust sales growth, globally totaling 2.81 billion yuan in 2024. Hanquyou is a China-developed monoclonal antibody biosimilar. It has received regulatory approval in China, the US and Europe, making it the most widely approved Chinese monoclonal antibody

Henlius' Hansizhuang drug is the world's first anti-PD-1 monoclonal antibody approved for treatment of small-cell lung cancer, a difficult-to-treat type of lung cancer. It has been approved for marketing in over 30 countries and regions, including China, Europe and Southeast Asia, benefiting more than 100,000 patients. In 2024, sales of the drug totaled 1.31 billion yuan, a 17 percent year-on-year gain.

On the research and development side, Henlius has built a pipeline of about 50 molecules, including monoclonal antibodies, polyclonal antibodies, antibody-drug conjugates and fusion proteins. The company leverages cutting-edge technologies such as artificial intelligence to address unmet clinical needs and enhance the successful rate of translational drug research.

Professor Lin Shen, a globally respected Chinese researcher in the treatment of gastric cancer in China, discussed the clinical development of Henlius' HLX22 drug when the company held a global research and development day.

HLX22 is designed to become the standard-of-care treatment for first-line gastric cancer treatment. The company has completed Phase 2 clinical studies and will announce its results at the annual meeting of the American Society of Clinical Oncology in June.

If the product's Phase 3 clinical trials return positive results, it will become an industry blockbuster, especially for China, which has an estimated 40 percent of global gastric cancer patients.

Henlius' HLX43 drug is also still in clinical trials. If successful, it would be a China first and the world's second antibody-drug conjugate targeting PD-L1, a protein that acts as a kind of "brake" to keep the body's immune responses under control. It can be used in the treatment of various cancers.

Henlius has won the trust of leading world scientists in cutting-edge drug development and commercialization. In June 2022, Henlius signed a partnership agreement with Palleon Pharmaceuticals, which was co-founded by US Professor Carolyn Bertozzi, who went on to win a Nobel Prize in chemistry later in the year.

In December 2024, Palleon and Henlius announced a collaboration and licensing agreement to develop Palleon's E-602, in combination with Helius' Hanlikang drug for treatment of autoimmune diseases, including lupus nephritis, an inflammation of the kidneys. Henlius has an exclusive license to E-602 in China, while Palleon retains all other global rights.

Palleon co-founder and Chief Executive Jim Broderick was also among those attending Henlius' research and development day.

In today's geopolitical environment, focusing only on drug research and commercialization is clearly not enough.

Henlius has just expanded its manufacturing base in suburban Shanghai to provide a steady stream of products for the global market. The company is deploying in-house AI drug development with proprietary data and is looking for external partners to enhance drug research efficacy.

The company said it has shortened drug molecular identification time from the typical 18 months to five months, aided by AI partner Insilico.

Though Henlius and other Chinese biotech companies may not yet be household names globally, they are firmly headed in that direction.

(The author has more than 20 years' experience in China's pharmaceutical and meditech realms and held senior executive positions in industries spanning oncology, neuroscience, corporate strategy, commercial operations and public affairs in China and the US. She was CEO of a Hong Kong-based biotech startup before founding her own business consulting firm.)