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First Patient Dosed in Phase 2 Clinical Trial of Henlius Anti-PD-1 mAb in Combination with Chemotherapy in Patients with Advanced Cervical Cancer

Shanghai, China, March 11, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first patient was dosed in a Phase 2 clinical trial (NCT04150575) of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with albumin-bound paclitaxel for the treatment of advanced cervical cancer. A total of eight clinical trials of immuo-oncology combination therapies with HLX10 is now ongoing in Henlius pipeline, including this Phase 2 trial.
According to the estimated data from GLOBOCAN, there was about 570,000 new cases of cervical cancer in 2018 globally, among which only 5.4% (~3,1000 cases) were from developed countries in Europe and North America. A total of 10,6000 new cervical cancer cases occurred in China in 2018 and took up 19% of all new cases around the world[1]. Most patients with cervical cancer are diagnosed at an age of 40~60. However, more and more studies have shown that the average age at diagnosis has a decreasing trend[2]. Current standard of care for advanced cervical cancer is concurrent chemoradiotherapy. Although there has been clinical data from several studies showing that anti-PD-1 mAbs had promising anti-tumour activity and good safety in the treatment of cervical cancer, the number of clinical trials conducted in China to further investigate in this direction is quite limited. There is great expectation from both physicians and patients for novel therapies for the treatment advanced cervical cancer. This Phase 2 study will investigate the treatment scheme to add an immune-oncology drug, HLX10, to chemotherapy and has positioned Henlius in the first tier in China in terms of clinical development stage in this area.

Reliable Quality Meeting International Standards

HLX10 is an innovative anti-PD-1 mAb independently discovered and developed by Henlius in accordance with international quality standards. It has the potential to be used in the treatment of multiple types of solid tumours and chronic hepatitis B infection. Currently, HLX10 has received the approvals of clinical trials in the US, Taiwan China and Mainland China. For both indications of MSI-H/dMMR solid tumours and chronic hepatitis B infection, first patients have been dosed in the two Phase 2 clinical trials respectively. In 2019 CSCO annual meeting and 2019 ESMO Asia annual meeting, Henlius shared the latest Phase 1 clinical trial (NCT02648490) results on the efficacy and safety of HLX10 in the treatment of advanced solid tumours, which showed that HLX10 was well-tolerated and elicited promising anti-tumour responses.

Combo: PD-1 immuno-oncology combination therapies

To improve the efficacy of anti-PD-1 mAb and to explore more treatment options, Henlius is actively implementing the differentiated strategy of “Combo+Global” with a focus on HLX10. Leveraging its broad and deep pipeline that covers tumour-specific targets, anti-angiogenesis targets and immune-oncology targets, Henlius is able to develop diversified immune-oncology therapies. Of note are dual mAb combinations consisting of HLX10 and another self-developed mAb (i.e. HLX04, a bevacizumab biosimilar or HLX07, an anti-EGFR mAb). Two clinical trials of HLX10 in combination with HLX04 have entered Phase 2/3. Additionally, five clinical trials of HLX10 combined with different chemotherapy regimens have also entered Phase 2/3 for the treatment of various solid tumours.

Besides, based on the well-established bispecific antibody engineering platform, relevant data and insights on PD-(L)1 pathway and on structure-activity relationship of anti-PD-1 antibodies that can be accumulated during the development of HLX10 will lay the foundation for Henlius future endeavours in the development of bispecific antibodies with PD-1 target.

Global: steadily entering the global market

Seeing the huge unmet medical needs in Southeast Asia, Henlius captured the opportunity by reaching a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize HLX10 in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries. Starting from Southeast Asia, Henlius will continue expanding the international layout of HLX10 and its combination therapies, gradually entering more emerging markets, and expanding to developed countries, to bring affordable innovative biologics to patients around the world.

About This Study (NCT04150575)

The study is a single-arm, open labelled, multi-centre Phase 2 clinical trial primarily aiming to evaluate the clinical efficacy of HLX10 in combination with albumin-bound paclitaxel in patients with advanced cervical cancer who have failed first-line standard chemotherapy. Secondary objectives include evaluating safety and tolerability of HLX10 combined with albumin-bound paclitaxel in the patient group, as well as exploring the possible correlations between biomarkers (PD-L1, MSI[3] and TMB[4]) and efficacy. Also, population pharmacokinetic and pharmacodynamic analysis will be performed.

About Henlius

Henlius (2696.HK) is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.HK.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 15 products and 8 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-center clinical trials are ongoing in various countries and regions worldwide.


[1]. GLOBOCAN 2018

[2]. 宫颈癌诊疗规范(2018版)

[3]. 微卫星不稳定性,microsatellite instability

[4]. 肿瘤突变负荷,tumor mutational burden