China's breast cancer biosimilar market sees a significant new entrant. HENLIUS has announced that its Pertuzumab Injection, HANBEYOU®, has received marketing approval from China's National Medical Products Administration. With this approval, HANBEYOU® has now completed registration across three major markets: China, the United States, and the European Union. It joins the company's previously approved trastuzumab biosimilar, HANQUYOU®, to form the first domestically developed trastuzumab-pertuzumab "dual-target" combination therapy to receive full approval in all three key regions.
Pertuzumab Competition Intensifies
Pertuzumab is a key targeted therapy for HER2-positive breast cancer, and its combination with trastuzumab as a "dual-target" regimen is now an international standard of care. For a long time, Roche's originator drug, Perjeta®, dominated the Chinese market, with domestic sales exceeding RMB 4 billion in 2024.
This substantial market opportunity has attracted numerous local pharmaceutical companies. In December 2024, Qilu Pharmaceutical's AnsaiZhu® and Sino Biopharmaceutical's PaLetan® were the first to gain approval, securing a first-mover advantage. In February 2026, Betta Pharmaceuticals' BeiZeTing® also successfully launched. With additional candidates in development from companies like CSPC Pharmaceutical Group, the pertuzumab biosimilar landscape has rapidly shifted from a "blue ocean" to a fiercely competitive "red ocean."
However, quantity does not equate to quality or guarantee final selection in clinical and procurement settings. As similar products flood the market, competition is shifting focus from single products to combination regimens.
In the comprehensive treatment of HER2-positive breast cancer, the combined use of trastuzumab and pertuzumab offers clear clinical benefits. This means only companies possessing both products can truly provide a complete dual-target solution, which has a substantive impact on hospital drug selection, physician prescribing habits, and reimbursement integration.
A Clear International Strategy
The approval pathway for HANBEYOU® is illustrative. In November 2025, under the brand name POHERDY®, it became the first pertuzumab biosimilar approved by the U.S. FDA. In February 2026, it gained approval in the EU, also as the first and currently only biosimilar of its kind in Europe. It finally returned for domestic launch in China in May 2026. This strategy of "first conquering high-barrier markets, then returning home" validates product quality and compliance capabilities while paving the way for entry into other emerging markets.
The launch of HANBEYOU® is a crucial piece of this strategic puzzle. From early-stage neoadjuvant therapy to postoperative adjuvant treatment and coverage of advanced metastatic breast cancer, and from China to the U.S., EU, and more countries along the Belt and Road, HENLIUS is attempting to build a comprehensive moat spanning both geography and the treatment continuum.
Market Dynamics Shift
Roche's long-standing dominance in China with its originator Perjeta® is being rapidly dismantled. With at least four domestic pertuzumab biosimilars now approved, and with Qilu Pharmaceutical and HENLIUS both offering complete dual-target combination capabilities, the choices for hospitals and patients have significantly expanded.
Particularly noteworthy are the preferential policies for biosimilars in China's National Reimbursement Drug List negotiations and the potential expansion of volume-based procurement. These factors are expected to further compress the pricing power of originator drugs. HENLIUS, with its manufacturing and sales capabilities across China, the U.S., and the EU, can not only compete in domestic substitution but also mitigate pricing pressures in any single market through overseas sales, achieving a more stable revenue structure.
It is foreseeable that over the next three to five years, domestically produced trastuzumab-pertuzumab combinations will become the mainstream choice for treating HER2-positive breast cancer in China. With its first-mover global compliance layout and complete dual-target product portfolio, HENLIUS has secured a key position in this quiet but intense competition.
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