复宏汉霖与甫康药业达成奈拉替尼全球战略合作

复宏汉霖将于近期全力推动汉奈佳^®步入商业化进程，与公司自主研发的曲妥珠单抗汉曲优^®（美国商品名：HERCESSI™，欧洲商品名：Zercepac^®）实现序贯治疗，有望进一步降低HER2阳性早期乳腺癌患者术后5年和10年复发风险，为患者带去治愈希望。

复宏汉霖高级副总裁兼首席商务发展官

曹平女士

复宏汉霖高级副总裁兼首席商务官

余诚先生

甫康药业创始人、董事长

沈孝坤博士

乳腺癌是全球女性发病率和死亡率最高的癌症，据国际癌症研究中心数据显示，2022年全球乳腺癌新发病例达230万^[1]。其中，HER2阳性乳腺癌约占全部乳腺癌的20%-25%^[2]，这类肿瘤细胞具有侵袭性强、恶性程度高、进展快等特点，并且，相较于其他分子亚型患者，HER2阳性早期乳腺癌患者在初始治疗后更易出现复发、转移，且超过30%的HER2阳性复发转移性乳腺癌患者会发生脑转移^[3]。为进一步降低复发风险、提高肿瘤治愈率，强化辅助治疗成为近年来乳腺癌治疗研究的重点。

奈拉替尼是一种新型口服、强效、不可逆的小分子泛HER激酶抑制剂（TKI），通过阻断泛HER家族（HER1，HER2和HER4）以及下游信号通路转导，抑制肿瘤生长和转移。已有临床研究结果表明，对于原发肿瘤较大、淋巴结阳性、新辅助治疗后病理未完全缓解的HER2阳性乳腺癌患者，在完成1年曲妥珠单抗（±帕妥珠单抗/T-DM1）标准辅助治疗后，继续使用奈拉替尼进行强化辅助治疗，能够显著降低患者复发风险^[4-6]，其中，降低2年和5年的复发风险分别达33%和27%, 并且，复发风险较高的亚组人群获益更加显著^[7-8]。此外，奈拉替尼作为小分子TKI，分子量小， 更易通过血脑屏障，可为预防脑转移提供新选择^[4]。截至目前，奈拉替尼已在中国、美国、欧洲、南美洲、非洲、东南亚等多个国家和地区获批上市，用于HER2阳性早期乳腺癌曲妥珠单抗辅助治疗后的强化辅助治疗。此外，奈拉替尼还相继获得《美国国立综合癌症网络（NCCN）乳腺癌临床实践指南》、《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南》、《中国抗癌协会乳腺癌诊治指南与规范》等国内外多部权威医学指南推荐。

复宏汉霖针对乳腺癌展开广泛布局，丰富的管线覆盖多款乳腺癌治疗产品，包括自主研发的中美欧三地获批单抗生物类似药汉曲优^®，其国际品质获得广泛认可，已在全球40多个国家和地区获批上市。此外，在研帕妥珠单抗生物类似药HLX11 国际多中心III期临床研究也在积极推进，并计划于2024年在全球范围内递交相关上市申请，有望进一步惠及全球更多患者。公司还获得了一款处于全球III期临床阶段的新型乳腺癌内分泌疗法lasofoxifene的亚洲权益，并于2024年5月获批在中国开展临床，拟用于ESR1突变的ER+/HER2-乳腺癌的治疗。围绕乳腺癌治疗，公司积极推进单药、联合疗法的临床研究，覆盖乳腺癌不同分期分型。此次引进的奈拉替尼在扩充公司乳腺癌治疗产品矩阵的同时，将与汉曲优^®发挥协同效应，为患者带去更佳生存获益。

未来，复宏汉霖将继续携手甫康药业等产业价值链上的合作伙伴，不断优化和拓展产品管线，以期为更多患者提供高品质、可负担的药物和治疗方案，助力提升全球肿瘤治愈率和生存率。

Henlius and Convalife Reach Global Strategic Cooperation on Neratinib

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.