Shanghai, China, August 19, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that it has reached a strategic cooperation with Convalife Pharmaceuticals (“Convalife”). Henlius is granted an exclusive license to commercialize neratinib, independently developed by Convalife, in China, as well as the exclusive negotiation and conditional licenses in agreed overseas countries and regions. Neratinib was approved by the National Medical Products Administration (NMPA) on June 28, 2024, under the brand name HANNAIJIA for extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Henlius will soon bring HANNAIJIA to market and promote it as sequential therapy after completion of HANQUYOU (Trastuzumab, HERCESSI™ in the U.S. and Zercepac® in Europe) that is self-developed by the company to further reduce the risk of recurrence for patients with early-stage HER2-positive breast cancer within 5 and 10 years after surgery, bringing hope of cure to patients.
Ping Cao, senior vice president and chief business development officer of Henlius, remarked, “Breast cancer is one of the areas that Henlius has been deeply engaging in. The cooperation with Convalife on neratinib will further enrich our product pipeline for breast cancer treatment and create synergy with HANQUYOU, helping enhance our market influence and competitiveness.”
Kurt Yu, senior vice president and chief commercial officer of Henlius, said, “Neratinib plays a significant role in the intensified treatment of HER2-positive breast cancer. Its introduction reflects our proactive response to diverse and personalized treatment needs. Leveraging mature commercial operation system and strong execution ability, we will accelerate the market expansion and clinical application of HANNAIJIA to benefit more patients.”
Dr. Xiaokun Shen, founder and chairman of Convalife, said, “I am grateful to Henlius for their trust in Convalife. HANNAIJIA as sequential therapy after completion of HANQUYOU will bring better benefit to patients. In the future, with the support of Henlius, HANNAIJIA is expected to enter the markets of the America, Europe, and many emerging countries. Relying on independently developed Right6D+AI technology platform, Convalife is continuously expanding the clinical indications of this neratinib as Class 2.4 new drug, such as lung cancer and gastric cancer, in order to further accelerate the development of innovative treatment solutions for patients worldwide.”
Breast cancer is the cancer with highest incidence and mortality rates among women globally. According to the data from the International Agency for Research on Cancer, there were 2.3 million new cases of breast cancer worldwide in 2022[1], among which, HER2-positive breast cancer accounts for approximately 20% to 25% of all breast cancer cases [2] and is characterized by strong invasiveness, high malignancy, and fast disease progression. Compared to other molecular subtypes of breast cancer, patients with early-stage HER2-positive breast cancer are more prone to recurrence and metastasis following initial treatment, and more than 30% of patients with HER2-positive recurrent metastatic breast cancer will develop brain metastasis [3]. To further reduce the risk of recurrence and improve the cure rate of tumors, intensive adjuvant therapy has emerged as a focus of the research in breast cancer treatment in recent years.
Neratinib is a novel, orally administered, potent and irreversible small-molecule pan-HER tyrosine kinase inhibitor (TKI) that inhibits tumor growth and metastasis by blocking the transmission of signals from the pan-HER family (HER1, HER2 and HER4) and downstream signaling pathways. The results of latest clinical studies have demonstrated that the HER2-positive breast cancer patients with large primary tumors, positive lymph nodes, and incomplete pathological remission after neoadjuvant therapy can obtain the significant reduction of the risk of recurrence if they continue the treatment with neratinib as an intensified adjuvant therapy after completing a 1-year standard regimen of trastuzumab (± pertuzumab/T-DM1) [4-6], resulting in a 33% and 27% reduction in the risk of recurrence at 2 and 5 years, respectively. Among subgroups with a higher risk of recurrence, the benefit was even more significant [7-8]. In addition, as a small-molecule TKI, neratinib is more likely to pass through the blood-brain barrier benefiting from its low molecular weight, which provides a new option in the prevention of brain metastasis [4]. Up to date, neratinib has been approved for marketing for intensive adjuvant treatment after adjuvant treatment with trastuzumab for HER2 positive early breast cancer in many countries and regions, including China, the United States, Europe, South America, Africa, and Southeast Asia. On the other hand, neratinib has been recommended by many authoritative medical guidelines at home and abroad, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, the Guidelines of Chinese Society of Clinical Oncology (CSCO): Breast Cancer, the Guidelines for Breast Cancer Diagnosis and Treatment by China Anti-cancer Association (CACA).
Henlius develops a comprehensive product layout in breast cancer, with a rich pipeline covering many antibody biologics and therapies, including HANQUYOU, a Chinese biosimilar approved in China, the United States, and the EU. It receives wide recognition for its world-class quality and has been approved for marketing in over 40 countries and regions worldwide. In addition, Henlius is actively promoting the global multi-centre phase 3 clinical trial of HLX11 (Pertuzumab biosimilar) and plans to submit its marketing applications globally in 2024, potentially benefiting more patients worldwide. Furthermore, the company also acquired the rights in Asia of a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global phase 3 clinical development. It was approved by the NMPA to conduct clinical trials in China for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation in May 2024. For breast cancer, Henlius actively promotes clinical studies on monotherapies and combination therapies, covering different staging and typing. The introduction of neratinib will expand the company’s product portfolio for breast cancer treatment and create synergy with HANQUYOU, bringing more benefits to patients.
In the future, Henlius will continue to collaborate with partners along the industrial chain, including Convalife, to optimize and expand product pipeline, aiming to provide more high-quality and affordable treatment solutions and contribute to improving cure rates and survival rates worldwide.
【Reference】
[1] International Agency for Research on Cancer. Global Cancer Observatory: Cancer Today [DB/OL]. http://gco.iarc.who.int/today [2024-02-01]
[2] Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40.
[3] Lin N.U., Amiri-Kordestani L., Palmieri D., et al. CNS metastases in breast cancer: old challenge, new frontiers. Clin Cancer Res. 2013;19(23):6404–6418.
[4] Holmes FA, et al. Improved central nervous system outcomes in patients with early-stage HER2-positive breast cancer who receive neratinib for the recommended duration: Findings from the phase 3 ExteNET trial. 2021 SABCS abs P2-13-21.
[5] Cognetti F, Di Cosimo S, Bruzzi P, et al. 139P - HER2+/HR+ breast cancer patients at high risk of relapse derive benefit from extended adjuvant treatment with neratinib: An exploratory analysis from ExteNET study. Ann Oncol. 2021;32(S5):S420.
[6] Harbeck N, Lüftner D, Breitenstein U, et al. 200TiP - ELEANOR: A multi-national, prospective, non-interventional study (NIS) in patients with human epidermal growth factor receptor (HER2) positive, early breast cancer (eBC) observing real-life extended adjuvant treatment with neratinib and concurrent use of the eHealth solution CANKADO. Ann Oncol. 2021;32(S5):S444.
[7] Chan A, Moy B, Mansi J, et al. Final Efficacy Results of neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial [published online ahead of print, 2020 Oct 6].Clin Breast Cancer. 2020;S1526-8209(20)30258-5. doi:10.1016/j.clbc.2020.09.014.
[8] Martin M, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688-1700.
About Convalife
Convalife Pharmaceuticals is a clinical-stage innovative drug development company based in China with a global outlook, committed to develop innovative medicines in the fields of oncology, virology, and age-related diseases. Guided by the unmet clinical needs globally, Convalife Pharmaceuticals designs and develops original innovative drugs with the potential to be "First-in-Class" or "Best-in-Class". Notable among its products are the second-generation PARP inhibitor CVL218, which has shown "Best-in-Class" potential. The world-leading highly selective PI3K β/δ dual inhibitor CVL237. The pipeline also encompasses "First-in-Class" innovative dual-specific antibodies for solid tumors. In the virology segment, Convalife's pipeline targeting a variety of infectious diseases, including COVID-19, Respiratory Syncytial Virus (RSV), Monkeypox virus, and Yellow Fever virus etc.