We made significant progress on our innovation agenda and saw great progress in R&D, manufacturing and commercialization in 2021. Along the journey of benefiting patients worldwide with high-quality biologics, we stayed true to our original aspiration, and made unremitting efforts. With the successive launching of HANBEITAI (bevacizumab) and the new indication rheumatoid arthritis (RA) of HANLIKANG (rituximab), we now have 4 products launched in China, 1 in Europe and 12 indications around the globe. New Drug Applications (NDAs) of serplulimab (anti-PD-1 mAb), our first innovative asset, have been accepted by the NMPA for review, with approvals expected in 2022. Up to date, we have benefited as many as over 170,000 patients worldwide.

We continue to unleash innovation potential by enhancing in-house capabilities and strengthening collaboration on external innovative assets. With serplulimab as the backbone, we carry out a total of 9 immuno-oncology combination clinical trials in the countries and regions including China, Turkey, Poland, Georgia, etc., covering a wide variety of indications including lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma, gastric cancer, etc. The international multi-center Phase 3 study of serplulimab in combination with chemotherapy in previously untreated extensive small-cell lung cancer (SCLC) reached the primary endpoint, potentially making serplulimab the first anti-PD-1 mAb for first-line treatment of SCLC in the world. With the close synergy between Shanghai and US Innovation Center, we gather pace in building our pipeline. In 2021, we saw robust clinical progress in 12 projects and received multiple clinical approvals on 6 candidates and 1 combination therapy worldwide, covering innovative targets such as 4-1BB, LAG-3, TIGIT, CD73, etc. Looking forward, we will advance “antibody-centric” innovations, expand new modalities and build a comprehensive “AXC” platform. Meanwhile, we continue to strengthen in-licensing through business development. In 2021, we licensed in HLX208, a small-molecule inhibitor targeting the human BRAF protein V600E mutation, an antibody targeting human TROP2 and other products, further expanding our presence in multiple cancer types.

We continue to sharpen our advantage of the integrated manufacturing platform. In 2021, we ramped up capacity progress in a bid to build competitiveness with economics of scale. Xuhui Facility currently has commercial capacity of 24,000L. We have completed the construction of 24,000L for Songjiang First Plant, which was approved for the manufacturing of HANQUYOU (trastuzumab) in 2021. Commercial capacity is expected to hit 48,000L in 2022. For the long-term plan, we have designed 96,000L for the Phase 1 project of Songjiang Second Plant, potentially making a total commercial capacity of 144,000L in 3 years. We have been committed to delivering products with “Henlius Quality” based on international standards. In 2021, we received Shanghai Drug Manufacturer Credit Assessment Grade A, the highest level of its kind. We strike a pioneer path of adopting new technologies with the first continuous manufacturing plant constructed in China. In 2021, we also succeeded in end-to-end continuous manufacturing and thus improving productivity with stable and controllable quality.

We continue to maximize commercial value of core assets. The domestic commercialization of HANQUYOU (Zercepac® in Europe), the first Chinese mAb approved in both China and Europe, is in the charge of our in-house commercial team. In 2021, we saw its robust growth in Chinese market. With the approval for the dual dosage form of 60mg/vial and 150mg/vial, we stand greater chance to reach more patients. In the overseas market, Zercepac® has been launched in nearly 20 European countries and regions including the United Kingdom, Germany, France, etc, with out-licensing covering more than 80 markets worldwide. In 2021, we continued to build up a stable and highly-efficient commercial team united by trust. We centered on patients and focused on marketing efficiency, as part of our efforts to realize a sound and sustainable development. While building HANQUYOU team, we are also gearing up for the advent of serplulimab by assembling immune-oncology team. Meanwhile, we expand the label for launched products. With the approval of HANLIKANG for the treatment of RA, HANLIKANG has become the rituximab with the largest number of approved indications in China, providing an alternative treatment option for patients with autoimmune diseases.

We delivered solid results in 2021. Looking beyond, we remain on a rapid growth trajectory with determination and move forward along the evolution from a biotech company to a biopharma by diversifying innovation through strategic collaboration and in-house innovation, globalizing manufacturing and quality system, localizing supply chain, and by maximizing the commercial value of late-stage assets. We will continue to extend the breadth of our value chain and refuel our momentum for development. Our heartfelt gratitude goes to shareholders and all walks of life for their great support and trust all along. There is no shortcut to follow but unrelenting efforts to pay on our way ahead. Down to the earth to touch the sky, my fellow colleagues and I will redouble our efforts for the development of China biopharmaceutical industry.