SHANGHAI, March 17, 2022 /PRNewswire/ — Henlius (2696.HK) announced its annual results for the year ended December 31st, 2021, sharing the company’s recent noteworthy progress and achievements. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 4 products launched in China, 1 in Europe, and 12 indications around the globe, focusing on oncology, autoimmune diseases, ophthalmic diseases, etc. Up to date, the company has benefited over 170,000 patients worldwide. In 2021, Henlius’ revenue increased by 186.3% year-on-year (YoY) to RMB 1.68 billion, primarily from sales of various products and licensing revenue. Among them, HANQUYOU (trastuzumab, Zercepac® in Europe) delivered solid growth in China and Europe, reaching a sales revenue of RMB 868.0 million with a 692.7% YoY increase and RMB 62.2 million from the Chinese market and international market, respectively. The company also received an oversea licensing revenue and revenue from R&D services of RMB 30.2 million.

Based on unmet clinical needs, Henlius also continues to unleash innovation potential by enhancing in-house capabilities and strengthening collaboration on external innovative assets. In 2021, the company’s R&D expenditure reached approximately RMB 1.76 billion. During the Reporting Period, the company saw robust clinical progress in 12 projects and received multiple clinical approvals on 6 candidates and 1 combination therapy worldwide. As of the Latest Practicable Date, more than 70 clinical trials have been approved worldwide, and more than a total of 20 clinical trials have been carried out in various countries and regions, including China, the European Union (EU), the United States (U.S.), Australia, the Philippines, and Turkey.

Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, remarked: “In 2021, we made significant progress on our innovation agenda as well as the evolution from a biotech company to a biopharma. We will continue to extend the breadth of our value chain and refuel our momentum for development. Our heartfelt gratitude goes to shareholders and communities for your great support and trust. Staying true to our spirit of ‘entrepreneurship, innovation and creation,’ we will do all we can for the development of China biopharmaceuticals.”

Accelerating the commercialization to step into a new stage

HANQUYOU (trastuzumab, Zercepac® in Europe) is the core anti-tumour product of Henlius indicated for the treatment of HER2 positive breast and gastric cancer patients, benefiting more than 40,000 patients to date. It is the first product commercialized by the company’s in-house commercial team that lays a favorable foundation for the overall increase in the sales of HANQUYOU. In 2021, HANQUYOU launched a new dosage form of 60mg. Together with the 150 mg form, HANQUYOU can flexibly meet the clinical medication needs of breast cancer patients with different body weights through more dosage forms and provide patients with personalized and more economical treatment plans. Moreover, Henlius is actively building an international commercial network for HANQUYOU and has joined forces with overseas partners such as Accord, a global pharmaceutical company, to promote the commercialization of Zercepac® in Europe, the Middle East and North Africa. In 2021, Zercepac® (150mg) has been successfully launched in nearly 20 European countries and regions, including the United Kingdom, Germany, France, Switzerland, and Spain. The new dosage forms of 60mg and 420mg were also approved in 2021 for marketing in the EU region. In addition, Henlius signed an agreement with Accord’s parent company, Intas, to further increase commercialization licenses in U.S. and Canada and its BLA is expected to be submitted to U.S. Food and Drug Administration (FDA) in 2022. To date, HANQUYOU has access to more than 80 countries and regions, spanning both mature and emerging markets.

HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA) in 2019. As of now, it has benefited more than 100,000 Chinese patients. The domestic commercial sales of HANLIKANG is being handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. In 2021, HANLIKANG (rituximab) received a profit-sharing of RMB 542.5 million from Fosun Pharma and licensing revenue of RMB 10.4 million. Up to date, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis (RA) for which the originator rituximab has not been approved in China, making it the rituximab with the most approved indications in China. This product is available with 2 dosage forms, 100mg/10ml and 500mg/50ml, allowing for more flexible drug dosing. In February 2022, HANLIKANG was approved for RA as the first rituximab approved for this indication in China. It will effectively improve patients’ quality of life with the advantages of low-frequency administration and long-lasting efficacy, reaching a broader patient population.

HANDAYUAN (adalimumab injection) is the company’s first monoclonal antibody for autoimmune diseases and was approved by the NMPA in December 2020. It is indicated for RA, ankylosing spondylitis, plaque psoriasis and uveitis.  Jiangsu Wanbang is responsible for the commercial sales of HANDAYUAN in China. By the end of 2021, the company received a profit-sharing of RMB 21.8 million and licensing revenue of RMB 1.0 million. Henlius actively expands the overseas distribution of HANDAYUAN, in February 2022, it entered into a collaboration agreement with Getz Pharma to commercialize HANDAYUAN in 11 emerging markets such as Pakistan, the Philippines, Vietnam, Nigeria, Kenya, Sri Lanka, Kazakhstan and Uzbekistan, thereby speeding up the company’s faster global commercialisation layout.

HANBEITAI (bevacizumab), approved by the NMPA in December 2021, is another marked product of Henlius in the field of oncology. It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Henlius is responsible for the commercial sales of HANBEITAI in China. In 2022, the company will actively promote the product’s access to basic medical insurance and hospitals, and gradually increase the sales under the ‘dual-channel’ scheme. Besides, Henlius plans to file a supplemental application for additional indications, including glioblastoma, hepatocellular carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in 2022.

PD-1 inhibitor serplulimab is about to be approved with outstanding readouts from Phase 3 trial in small cell lung cancer

The serplulimab (innovative anti-PD-1 monoclonal antibody) is the first innovative monoclonal antibody independently developed by Henlius and also a significant milestone in the company’s evolution toward Biopharma. Two indications of serplulimab are expected to be approved by NMPA in 2022, in which the NDA of its first indication for the treatment of microsatellite instability-high (MSI-H) solid tumours has been accepted with priority review and is expected to be approved in the first half of 2022. An NDA for another indication, locally advanced and metastatic squamous non-small cell lung cancer (sqNSCLC), has also been accepted. In preparation for the launch of serplulimab, Henlius aimed to recruit around 200 people within 2022 and quickly implement a differentiated strategy for market penetration.

With serplulimab as the backbone, a total of 9 immuno-oncology combination therapies clinical trials are ongoing worldwide in a wide variety of high-incidence solid tumours, including lung cancer (LC), hepatocellular cancer, esophageal carcinoma, head and neck carcinoma, gastric cancers, etc. Henlius has carried out a comprehensive first-line treatment layout for LC in sqNSCLC, nsNSCLC and small cell lung cancer (SCLC), which covers more than 90% of lung cancer patients. Two international multi-center Phase 3 clinical trials are ongoing for sqNSCLC and SCLC in China, Turkey, Poland, Georgia and other countries and regions, enrolling more than 30% of Caucasians. In December 2021, the Phase 3 clinical study (ASTRUM-005) of serplulimab in combination with chemotherapy for the treatment of SCLC met the primary study endpoint of the overall survival (OS) with remarkable readouts and the NDA in China and the EU are expected to be submitted in 2022, making serplulimab potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. By the end of 2021, over 2,800 patients have been enrolled worldwide. The company has accumulated abundant international clinical research data that can strongly support future fillings in mainstream markets such as U.S. and the EU.

The pipeline expansion is fueled by innovation, resulting in a robust global R&D layout

Rooted in unmet medical needs, Henlius strives to promote its innovation and R&D capabilities. Synergising the Innovation centres in China and the US, the company continues the momentum for a diversified innovation with independent development accounts for over 80% of the product pipeline by enhancing internal innovation capacities and reaching out to more strategic partners. The company aggressively pushes its early R&D research capabilities further while also upgrading its technology platform. Henlius is currently looking into novel coupling techniques in effort to grow its presence in antibodies and oncology, while also focusing on the non-oncology therapeutic areas such as metabolism, cardiovascular, inflammation, etc., with the aim of advancing candidates for a promising pipeline.

In 2021, Henlius promoted in-depth research and development, unlocking the potential of the novel candidate targets including TIGIT, 4-1BB, BRAF V600E, LAG-3, CD73, etc. The two potential first-in-class bispecific antibodies, HLX301 (anti-PD-L1×TIGIT bispecific antibody) and HLX35 (anti-4-1BB×EGFR bispecific antibody), has completed the first subject dosing in Phase 1 clinical study in Australia. Meanwhile, the company’s new ophthalmic preparation product HLX04-O (anti-VEGF monoclonal antibody), independently developed through optimizing the prescription, specifications and production processes of HANBEITAI, was approved to carry out clinical trials in China, Australia, U.S., the EU, Singapore, and other countries. The company will advance the international multi-center clinical trials in 2022. In addition, a Phase 2 clinical trial of HLX22, an anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection, in combination with HANQUYOU and chemotherapy as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients has completed the first subject dosing in 2021.

Henlius has also committed to replenishing the innovative candidate targets through in-licensing. The company’s in-licensed product HLX208 (BRAF V600E inhibitor) has been approved by the NMPA for conducting clinical trials. It has the potential to be used in combination with the company’s multiple candidate targets and create new combinations that unlock additional indications such as LC and mCRC. Recently, it has been dosed in patients with Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) with BRAF V600E mutation. Next, Henlius will tap its potential for a broader range of indications and patients.

Integrated manufacturing platform ensures high-quality large-scale production

The company continue to build an integrated manufacturing platform, translating its R&D efforts into social impact and commercial results. The company’s commercial capacity reached 24,000L in 2021, and that in 2022 is expected to double. Towards 2025, the design capacity is planned to rise from 84,000L to 144,000L. In 2021, Xuhui facility, certificated by China and the EU GMP earlier, has ramped up its capacity from 20,000L to 24,000L. The company is also exploring localized alternatives for key materials and process development approaches to mitigate the risk of supply shortages and a lack of supporting facilities under the current international situation. Moreover, the Phase I project of Songjiang First Plant was approved for the manufacturing of HANQUYOU with the goal of putting its constructed 24,000L capacity into operation in 2022 and passing the FDA GMP inspection in the first half of 2023. The Phase I project of Songjiang Second Plant has a planned total capacity of 96,000L to get Henlius well positioned for its fast-growing industry transformation and global commercialisation blueprint. In detail, the first and second stages of this project aim to achieve a total capacity of 36,000L. They are expected to enter trial production and relevant verifications in the second half of 2022. In addition, plans are underway for the third stage of this project. The construction of its 60,000L capacity is scheduled to commence in 2022.

While ramping up capacity progress, the company is determined to accelerate the development and industrialisation of advanced production techniques such as continuous manufacturing technology and achieve economies of scale, leading to a rapid decline in the cost of its products and a streamlined manufacturing process. In 2021, the company successfully launched China’s first continuous manufacturing clinical production workshop to achieve end-to-end continuous production and thus improving productivity with stable and controllable quality.

Going forward, Henlius will keep its innovation momentum pivoting on unmet clinical needs, continue to round out its diversified development strategy of enhancing in-house capabilities and strengthening collaboration on external innovative assets, and intensify efforts to foster innovation and make great progress in R&D, manufacturing and commercialisation, evolving into a more full-fledged biopharma with keener competitiveness.