Henlius Achieved Steep Revenue Growth in Q1 2023, Core Products Sales Surged

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SHANGHAI, April 16, 2023 /PRNewswire/ -- As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 5 products launched in China. Leveraging the differentiated competitive edges of its products, Henlius adopts meticulous management model and precise market strategies to optimize the commercialization layout and further extend its market reach. In the first quarter of 2023, Henlius'revenue climbed 97.2% to RMB995.7 million. With expanding sales of its flagship products including HANQUYOU and HANSIZHUANG, the company has shown continous revenue growth.

HANQUYOU Continues to Soar

In the first quarter of 2023, Henlius' core anti-tumour product HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®, trade name in Australia: Tuzucip^® and Trastucip^®) extended its strong momentum, soaring by 66.7%, to RMB538.6 million.

HANQUYOU, indicated for the treatment of HER2-positive breast cancer and gastric cancer, is the first product sold and promoted in Chinese mainland by the company's in-house commercialisation team. The 150mg/60mg dual dosage and preservative-free formulation of HANQUYOU sets it apart, leading clinical practices and providing a personalized and cost-effective treatment option for breast cancer patients of any weight. In 2022, the 24,000L production capacity of Songjiang First Plant was approved to commence the commercial production of HANQUYOU, being a driving force behind the production increase and the accerlerated commercialisation of HANQUYOU. Furthermore, Henlius continues to expand the sales network of HANQUYOU. As at the end of 2022, the copany had more than 550 sales agents for HANQUYOU, with the goal of penetrating the Chinese mainland markets with efficiency far exceeding the industry average.

HANQUYOU is the first China-developed mAb approved both in China and Europe. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. In February 2023, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA), which will further expand the product's footprint in major markets of biologics in the U.S. and Europe. In addition, Henlius has aggressively pursued international commercialization of HANQUYOU, actively collaborating with global partners to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to now, HANQUYOU has launched in over 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 first innovative product, HANSIZHUANG (serplulimab) achieved a domestic sales revenue of RMB249.8 million. Notably, HANSIZHUANG realized a monthly sales of over RMB100 million in March 2023 in Chinese mainland, starting a new stage of its sales growth as well as providing strong momentum for the product's commercialization.

HANSIZHUANG was launched in China in March 2022，and 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) so far. As the world's first anti-PD-1 monoclonal antibody (mAb) for the first-line treatment of SCLC, HANSIZHUANG set a record for SCLC immunotherapy with a median OS (overall survival) of 15.8 months. With its outstanding quality and clinical efficacy, HANSIZHUANG has earned wide recognitions from the market and has seen rapid sales uptick. At the beginning of the product's commercialisation, an amazing "Henlius speed" has been demonstrated in the first deliveries and the first prescriptions of HANSIZHUANG, which also indicated the company's strong commercial operation and execution. As of the end of 2022, its sales team has been expanded to approximately 400 people. With a rich experience in oncology and meticulous management model, the team has covered over 23,000 healthcare providers from nearly 1000 domestic hospitals. Looking forward, the company will continue to accelerate the market coverage and penetration of HANSIZHUANG in the areas of lung cancer, gastrointestinal and gynecological tumours.

In March 2023, the European Medicines Agency (EMA) has validated the Marketing Authorization Application(MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC. Another patient has also been dosed in a head-to-head bridging trial of HANSIZHUANG versus first-line standard of care atezolizumab for ES-SCLC in the U.S. The company also plans to submit a Biologics License Application (BLA) for HANSIZHUANG in the U.S. in 2024. Meanwhile, the company continues to explore the 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 better therapies for the patients, more than 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications.

Looking forward, Henlius will continue to delve into the area of oncology, auto-immune and other diseases. While maximizing the commercial value of biosimilars at home and abroad, Henlius will actively explore innovation drugs and tackle unmet clinical needs by leveraging its in-house R&D capabilities supplemented by external cooperation and license-in, so as to consolidate the best-in-class capabilities of "integrated research, manufacturing and commercialisation", and achieve steady development as a larger, international and more profitable Biopharma to provide more affordable and better therapies for patients worldwide.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG 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. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

SOURCE Henlius