In 2023, Henlius’ commercialization strategy has paid off, as their revenue skyrocketed by 97.2% to RMB995.7 million. The company has leveraged its innovative biopharmaceuticals and differentiated competitive edges to gain a strong presence in the market, with five products launched in China and its flagship products, HANQUYOU and HANSIZHUANG, leading the charge.
Henlius is dedicated to providing high-quality, affordable and innovative biopharmaceuticals to patients worldwide, and their success in the first quarter of 2023 is testament to this commitment.
HANQUYOU Continues to Soar
In the early months of 2023, Henlius’ HANQUYOU (trastuzumab, Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) continued to show its remarkable strength, as its revenue skyrocketed by 66.7% to a remarkable RMB538.6 million.
Henlius made history in the Chinese mainland in 2021 when it launched its first product, HANQUYOU, for the treatment of HER2-positive breast cancer and gastric cancer. This prescription medication sets itself apart with its dual dosage of 150mg/60mg and preservative-free formulation, making it a personalized and cost-effective treatment option for patients of any weight.
In 2022, its 24,000L production capacity of Songjiang First Plant allowed the company to begin commercial production of HANQUYOU, enabling it to penetrate the Chinese mainland markets with efficiency far beyond the industry average. As of the end of the year, Henlius had more than 550 sales agents for HANQUYOU, a testament to its commitment to providing greater access to the innovative treatment.
HANQUYOU, the first China-developed mAb, has been approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020 respectively. The Biologics License Application (BLA) for HANQUYOU was accepted by the U.S. Food and Drug Administration (FDA) in February 2023, paving the way for its expansion in major biologics markets.
Henlius has been relentless in its pursuit of international commercialisation of HANQUYOU, actively collaborating with global partners to bring its therapeutics to over 100 countries and regions. HANQUYOU has already been launched in more than 30 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Singapore, Argentina and Saudi Arabia.
HANSIZHUANG Sees Unbated Growth
In the first quarter of 2023, the company’s innovative product, HANSIZHUANG (serplulimab), made a smashing entrance into the market, achieving a domestic sales revenue of RMB249.8 million. Even more remarkable, HANSIZHUANG reached an astounding milestone in March 2023, with its monthly sales revenue surpassing the RMB100 million mark in the Chinese mainland, signifying the start of a new era of its commercial success.
March 2022 marked the launch of HANSIZHUANG in China, the world’s first anti-PD-1 monoclonal antibody (mAb) for the first-line treatment of SCLC, and it has been approved for 3 indications including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC).
Already, HANSIZHUANG has broken records with an incredible median OS (overall survival) of 15.8 months, earning widespread acclaim and a rapid sales uptick. It’s no wonder with the incredible “Henlius speed” demonstrated in the first deliveries and prescriptions of HANSIZHUANG, the result of its strong commercial operation and execution.
By the end of 2022, the sales team had grown to 400 people, each with a wealth of oncology experience and a meticulous management model. They have already covered over 23,000 healthcare providers from nearly 1000 domestic hospitals, and the company is only working to accelerate the market coverage and penetration of HANSIZHUANG in the areas of lung cancer, gastrointestinal and gynecological tumours.
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for HANSIZHUANG as a first-line treatment for ES-SCLC and a head-to-head bridging trial of HANSIZHUANG versus first-line standard of care atezolizumab is underway in the U.S. Furthermore, a Biologics License Application (BLA) for HANSIZHUANG is planned for submission in 2024.
In addition, the company is exploring various combination therapies between HANSIZHUANG and self-developed products such as HANBEITAI, HLX07 (anti-EGFR mAb), HLX26 (anti-LAG-3 mAb), HLX208 (BRAF V600E small molecule inhibitor) and HLX60 (anti-GARP mAb) to provide improved treatments for patients. Currently, more than 10 clinical trials on immuno-oncology combination therapies are being conducted in a variety of indications.
Henlius is pushing the boundaries of oncology, auto-immune, and other diseases, aiming to maximize the commercial value of biosimilars both domestically and internationally. But that’s not all; the biopharma is also actively exploring innovative drugs and seeking to fill unmet clinical needs, both through its own in-house R&D capabilities and through external collaborations and license-ins.
With this integrated approach to research, manufacturing, and commercialisation, Henlius is making strides towards becoming a larger, global, and more profitable biopharma, providing more affordable and better therapies to patients around the world.
Henlius is an innovative biopharmaceutical company that is committed to providing high-quality, affordable treatments to patients all around the world. Having launched five products in China and one in overseas markets, and with eighteen approved indications worldwide and three more applications being reviewed in China, the U.S. and the EU, Henlius has already established itself as a major player in the biopharmaceutical industry.
This success has been achieved by building an integrated platform that boasts cutting-edge research and development, manufacturing, and commercialization capabilities, as well as two globally recognized manufacturing facilities, the Xuhui Plant (certified by both China and the EU) and the Songjiang First Plant (certified by China).
Henlius is leading the way with a diverse and high-quality product pipeline of over 20 innovative monoclonal antibodies (mAbs). Its flagship product HANSIZHUANG (anti-PD-1 mAb) has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.
In addition, HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), and HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab) have been launched. Henlius is also exploring immuno-oncology combination therapies and its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. With over 30 clinical studies conducted for 16