First Patient dosed in a Head-to-Head First-Line Bridging Study of HANSIZHUANG for ES-SCLC treatment in the US

SHANGHAI,Nov. 30,2022 --Shanghai Henlius Biotech,Inc. (2696.HK) announced that the first patient was dosed in NCT05468489,a bridging head-to-head trial in the United States comparing HANSIZHUANG (serplulimab),an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the company to standard of care Atezolizumab (anti-PD-L1 mAb). Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and the discussion results of the FDA's Class C consultation meeting,Henlius plans to recruit 100 pairs of US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG.

In April 2022,the company announced that US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG for the treatment of small cell lung cancer (SCLC). The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States. In China,the New Drug Application (NDA) of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC has been accepted by the National Medical Products Administration (NMPA). At present,there is no anti-PD-1 mAb approved for the first-line treatment of SCLC worldwide. HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.

Innovate to further advance

SCLC is the most aggressive subtype of lung cancer,accounting for 15% to 20% of all lung cancer cases. SCLC exhibit high malignancy,strong invasiveness,early metastasis,fast disease progression,and a poor prognosis. At present,anti-PD-L1 mAbs combined with chemotherapy have been recommended by clinical practice guidelines abroad as the first-line treatment for ES-SCLC,but there is no anti-PD-1 mAb approved worldwide,suggesting the need for more effective treatments in this patient population.

Henlius has conducted an international multi-centre phase 3 study of HANSIZHUANG plus chemotherapy as first-line treatment for patients with ES-SCLC. The study has set up a total of 128 sites in various countries including China,Turkey,Poland,and Georgia,and enrolled 585 subjects who were screened from 114 sites,among whom 31.5% were White. The results of ASTRUM-005 were presented for the first time in an oral report at the 2022 ASCO annual meeting,and ASTRUM-005 went on to become the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA,impact factor of 157.3),one of the top four medical journals in the world. As of data cutoff for the interim analysis (October 22,2021),median overall survival (OS) was significantly longer in the serplulimab group (15.4 months) than in the placebo group (10.9 months),forming a new world record. In addition,the study showed good safety and consistent efficacy over time.

Comprehensive Layout

HANSIZHUANG is the first innovative mAb developed by Henlius. Up to date,2 indications are approved for marketing in China,2 NDAs have been accepted by the NMPA. Since launchedin March 2022,HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer,benefiting more than 9,700 Chinese patients. Its synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China,the United States,the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies in a wide variety of indications,such as lung cancer,esophageal carcinoma,head and neck squamous cell carcinoma and gastric cancer,etc.,and covering the full range of first-line treatments of lung cancers. As of now,HANSIZHUANG has enrolled more than 3,100 subjects around the world,and the proportion of White is over 30% in two MRCTs including ASTRUM-005. Such a large amount of global clinical data is also expected to bolster the marketing approval of HANSIZHUANG in overseas markets such as the European Union and to lay a foundation for global clinical application. The bridging trial carried out in the United States will also further promote the global development of HANSIZHUANG.

In the future,the company will continue to emphasize unmet clinical needs,actively promote the progress of this bridging study and the combination immunotherapy of serplulimab,offering high-quality,affordable,and innovative medicines to patients worldwide.

About NCT05468489

This randomised,open-label clinical study aims to compare the efficacy and safety of serplulimab with atezolizumab (anti-PD-L1 mAb)when combined with chemotherapy (carboplatin-etoposide) in previously untreated US patients with extensive-stage small cell lung cancer (ES-SCLC). Eligible patients will be randomised 1:1 to receive intravenous infusion of either serplulimab (300 mg) or atezolizumab (1200 mg) in combination with chemotherapy every 3 weeks. The primary objective of this study is to compare the efficacy of the two treatment regimens in previously untreated US ES-SCLC patients. Secondary objectives are to evaluate the efficacy,safety,pharmacokinetics,and immunogenicity of serplulimab in combination with chemotherapy. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS),PFS2,objective response rate (ORR),duration of response (DOR),pharmacokinetic characteristics,and immunogenicity.

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 approved for marketing in overseas markets,15 indications approved worldwide,and 4 New Drug Applications (NDAs) accepted for review in China. 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; 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 tumours and squamous non-small cell lung cancer (sqNSCLC). Its NDAs for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) are under review. What's more,Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies,expanding its presence in major markets as well as emerging markets.