Next City Henlius Innovative Anti-PD-1 Monoclonal Antibody H Drug Hans Form? Approved for the treatment of squamous non-small cell lung cancer

Shanghai, November 1, 2022 – November 1, 2022, – Henlius (2696.
HK) announced that its first self-developed innovative biological drug anti-PD-1 monoclonal antibody H drug - hans-form ^® (generic name: serplulimab injection) new indication application has been approved by the National Medical Products Administration (NMPA), combined with carboplatin and albumin paclitaxel for the first-line treatment of inoperable resectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), providing a new drug option
for lung squamous cell carcinoma patients 。 Previously, drug H has been approved for the treatment of highly unstable microsatellite (MSI-H) solid tumors, and the wide range of indications has promoted the benefit
of more patients.

Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, said: "The approval of sqNSCLC for H drug marks the official application of this high-quality anti-PD-1 monoclonal antibody in the clinical treatment of lung cancer, benefiting patients with international quality and further enhancing the influence of
H drug in this field.
Henlius has carried out a diversified layout and clinical research on multiple related indications is steadily advancing, looking forward to more positive clinical results in the future, synergizing with the unique advantages of H Drug, and making new contributions
to tumor treatment.
"

Professor Zhou Caicun, principal investigator of phase III clinical study of H drug sqNSCLC, director of the Department of Oncology of Shanghai Pulmonary Hospital affiliated to Tongji University and director of the Cancer Institute of Tongji University School of Medicine, said: "sqNSCLC accounts for about 25%-30% of non-small cell lung cancer (NSCLC), which is the second largest subtype of NSCLC, and the clinical demand is greater
.
The international multicenter clinical trial of serplulimab for sqNSCLC is the largest international clinical study of sqNSCLC led by Chinese investigators, with a total of more than 500 subjects
enrolled worldwide.
The results showed that serplulimab had reached the preset primary endpoint and significantly prolonged progression-free survival (PFS).

The positive results of this study are another positive benefit of tumor immunotherapy, and it is expected to benefit
more patients in clinical practice.
"

International quality to meet more clinical needs

The approval is mainly based on a randomized, double-blind, international multicenter phase III clinical study (ASTRUM-004), which has opened research centers in many countries around the world, including China, the European Union, Poland, Turkey and other countries, of which the proportion of whites is more than 30%, sufficient international clinical trial data is expected to support the declaration of overseas markets, and also lay the foundation
for global clinical application 。 Clinical studies have shown that the combination of carboplatin and albumin paclitaxel in patients with locally advanced or metastatic sqNSCLC who have not received treatment has significant benefits, meets the preset primary endpoint, and has a good safety and tolerability profile
.

Lung cancer is one of the most common cancers in the world and has the highest incidence and mortality in China
.
According to the latest national cancer statistics released by the National Cancer Center, there are 828,000 new cases of lung cancer and a total of 657,000 deaths^[1].

NSCLC accounts for approximately 80 to 85 percent of all lung cancers ^[2], and approximately 50 percent of patients with NSCLC are locally advanced or metastatic
at the time of diagnosis.
Advanced sqNSCLC accounts for about 30% of advanced NSCLC, and the treatment mode is mainly platinum-containing double-drug chemotherapy, the efficacy is not ideal, and the median survival of patients is short, many of which do not exceed 1 year, so there is a huge unmet medical need
in this field 。 In recent years, immune checkpoint inhibitors have made many breakthroughs in clinical treatment, and have also made great progress in NSCLC, especially anti-PD-1 monoclonal antibody combined with carboplatin + albumin paclitaxel for the treatment of advanced or metastatic sqNSCLC has been recommended by NCCN, CSCO and other authoritative guidelines at home and abroad, and promoted advanced NSCLC into the era of
immunotherapy.
The approval of drug H will bring new drug options to this pathological subtype, promote the wider application of immunotherapy in the clinical treatment of lung cancer, and further promote the innovation and development of
lung cancer treatment.

Continuous innovation to cultivate the first-line treatment of lung cancer

As the first innovative monoclonal antibody of Henlius, H drug has a wide range of indications and has carried out more than 10 clinical studies of immune combination therapy around the world, covering lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer and other high-incidence cancers, with a cumulative enrollment of more than 3,100 subjects worldwide.

In the field of lung cancer, H drug comprehensively covers its first-line treatment, in addition to sqNSCLC, clinical trials
are also carried out in the fields of non-squamous non-small cell lung cancer (nsqNSCLC) and small cell lung cancer (SCLC).
Among them, the phase III clinical trial of H drug in the treatment of extensive-stage small cell lung cancer (ES-SCLC) has achieved positive results, and it is the world's first anti-PD-1 monoclonal antibody
with positive results for the first-line treatment of ES-SCLC.
At present, the marketing application for this indication has been accepted by the NMPA, and it is expected to become the world's first anti-PD-1 monoclonal antibody
for the first-line treatment of SCLC.
In terms of NSCLC, Henlius is also actively carrying out a number of clinical studies, including H drug combined with innovative anti-EGFR monoclonal antibody HLX07 first-line treatment of EGFR high-expression sqNSCLC, H drug combined with Hambeta ^® (bevacizumab) first-line treatment of nsqNSCLC.

The company is deeply engaged in the field of lung cancer, continuously expands the layout of indications for this field, and helps lung cancer patients achieve higher quality long-term survival
with innovative combination treatment programs.

"Patient-centered" is the fundamental value of Henlius' R&D, and we will continue to use this as a driving force for innovation, and strive to solve the difficulties and pain points of clinical treatment, so that patients can achieve high-quality and longer-term survival
.
H drug will also carry the mission of saving more patients, continue to explore and make breakthroughs in the field of lung cancer and more tumors, and give more patients the power to
live.

References

[1] Rongshou Zheng,Siwei Zhang,Hongmei Zeng, et al.
Cancer incidence and mortality inChina, 2016.
Journal of the National Cancer Center, 2022, ISSN 2667-0054, dio:10.
1016/j.
jncc.
2022.
02.
002

[2] About Lung Cancer.
American Cancer Society.