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HANSIZHUANG (serplulimab) is the world's first anti-PD-1 mAb for first-line treatment of ES- SCLC - HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES- SCLC - HANSIZHUANG (serplulimab) has already been approved in China, Indonesia, Cambodia, and Thailand, benefiting around 80,000 patients SHANGHAI, Sept. 21, 2024 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of HANSIZHUANG (serplulimab), Henlius' independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). In 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation a total of more than 50 countries in Europe and India. This positive opinion from CHMP marks another step closer for both companies to providing serplulimab for patients in Europe. If approved, serplulimab will be marketed by Intas' subsidiary, Accord Healthcare Ltd, in Europe. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius' patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide." Paul Tredwell, Executive Vice President of EMENA at Accord, said, "I am thrilled with the CHMP's positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis." Innovative Approach to Address Clinical Needs of SCLC According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases.[1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer, which is featured by high malignancy, early metastasis, and rapid disease progression, with extremely poor prognosis. SCLC is divided into limited-stage and extensive-stage, with approximately 30%-40% of patients diagnosed at the limited stage and the rest at the extensive stage. With a prevalence of 1-5 per 10,000 people in the European community, SCLC has an orphan disease designation.[2] In December 2022, HANSIZHUANG was granted orphan drug designation by the European Commission (EC) for the treatment of SCLC, and in March 2023, EMA validated the marketing authorisation application (MAA) of HANSIZHUANG for ES-SCLC. The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. The study has set up a total of 128 sites in various countries including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were Caucasians. The ASTRUM-005 clinical trial results were firstly presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), making it the first study published on JAMA in SCLC immunotherapy. Based on the ASTRUM-005 study, HANSIZHUANG has been approved in China and Southeast Asian countries for first-line treatment of ES-SCLC, making it the world's first anti-PD-1 mAb approved for first-line treatment of SCLC. Global Strategy to Fuel Innovation-driven Expansion HANSIZHUANG, Henlius' first innovative mAb developed in-house, focuses on high-incidence cancers such as lung cancer and gastrointestinal tumours. In China, it has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC). The company is also conducting more than 10 clinical studies on immuno-oncology combination therapies worldwide. Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to sqNSCLC and ES-SCLC, HANSIZHUANG's marketing application for first-line treatment of non-squamous NSCLC (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). Additionally, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). Henlius is also running a bridging head-to-head trial in the U.S. to compare HANSIZHUANG with standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards U.S. market approval further. The global expansion of HANSIZHUANG is accelerating. It has already been approved in several countries, including China, Indonesia, Cambodia, and Thailand, and has been licensed to over 70 countries and regions, including the US, Europe, Southeast Asia, the Middle East, and North Africa. On December 2023, Henlius received the European Union (EU) GMP Certificates for the production lines of HANSIZHUANG, marking that the company's Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The first overseas shipment of HANSIZHUANG was completed in Q1 2024, making it the first Chinese anti-PD-1 mAb to enter Southeast Asian, offering new treatment options for more global patients. Looking ahead, Henlius will continue to prioritize patient needs, address unmet clinical demands, and accelerate efforts to deliver high-quality biologics from China to patients worldwide. References [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 [2] Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207 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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules 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: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, May 24, 2024 /PRNewswire/ -- Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech developing innovative Tumor-Infiltrating Lymphocyte (TIL) therapies for cancers, announced latest clinical research results on GC203 (a novel non-viral vector gene-modified TIL therapy engineered with membrane-bound IL-7). These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place on May 31 - June 4, 2024. Researchers tested GC203 on patients diagnosed with recurrent ovarian cancer, without the combination of IL-2 administration or aggressive lymphodepletion. The objective of the study was to determine the safety and efficacy of this treatment. A total of 20 patients were enrolled between 09/2021 and 01/2024 in the open-label single-center trial, in which 18 patients were evaluable. The evaluable patients were with an ECOG PS of 1 (55.6%) or 2 (44.4%) and received a median of 5 previous systemic therapies (range: 2-11). 9 (50%) patients had 3 or more tumor lesions. The median target lesion size was 57 (range: 13-146) mm. GC203 showed promising results in patients with recurrent or metastatic ovarian cancer. The safety profile was improved significantly compared with conventional TIL therapies, thanks to a low-intensity pretreatment and the elimination of IL-2 combination. Most of the Adverse Events (AEs) were grade 1 or grade 2 and could be alleviated or cured by symptomatic treatment. No grade 5 event occurred. By the cutoff date of 01/2024, the investigator-assessed Objective Response Rate (ORR) was 33.3% (95% CI: 16.3 - 56.3), including 11.1% Complete Response (CR). The Disease Control Rate (DCR) was 83.3% (95% CI, 60.8 - 94.2). And the 12-month Overall Survival (OS) rate was 68.8% (95% CI: 49.3 - 95.9). The median OS was not mature as data cut-off. Presentation Details Abstract Number: 5552 Abstract Title: A phase I single-arm, open-label trial of engineering tumor-infiltrating lymphocytes with membrane-bound lL-7 for recurrent ovarian cancer. Session Type and Title: Poster Session - Gynecologic Oncology Poster Presentation Time: 9:00 AM - 12:00 PM CDT, June 3, 2024 Presenter: Dr. Jing Guo, Shanghai Tenth People's Hospital The abstract is available on the ASCO website. About Ovarian Cancer Ovarian cancer has the highest mortality rate among gynecologic cancers. 70% of patients are diagnosed at an advanced stage. 70% of patients with advanced ovarian cancer have a survival time of less than five years. More than 200,000 people worldwide die from ovarian cancer each year, indicating a significant unmet clinical need. The primary treatment for advanced ovarian cancer is platinum-based chemotherapy. Ovarian cancer is insensitive to immunotherapy, with an ORR of less than 10%. Effective treatment options are limited. About GC203 GC203 is a novel non-viral vector gene-modified TIL therapy developed leveraging Juncell Therapeutics' proprietary DeepTIL® cell expansion platform and NovaGMP® gene modification platform. DeepTIL® enables TILs to be potent enough that no IL-2 combination will be required after infusion, and the intensity of pretreatment could be lower. NovaGMP® modifies T cells with a high efficiency comparable with the Lentiviral vector in an economic way. GC203 is engineered with self-associating membrane-bound interleukin-7, which can maintain the stemness of memory T cells, activate internal immune cells and avoid systemic toxicities. About Juncell Therapeutics Juncell Therapeutics is a biotech dedicated to developing high-quality, accessible TIL cell therapies for the treatment of solid tumors. Juncell Therapeutics has established its proprietary DeepTIL® cell expansion and NovaGMP® gene modification technology platforms, which are designed to address the key challenges of conventional TIL therapies, making TILs "robust, competent, affordable, and accessible." Two clinical-stage TIL therapies have demonstrated promising safety and efficacy in the treatment of nine types of heavily pretreated advanced solid tumors, including lung cancer, triple-negative breast cancer, pancreatic cancer, high-grade glioma, ovarian cancer, endometrial cancer, cervical cancer, bile duct cancer and melanoma. 7 of these late-stage tumor patients have achieved CR, and the longest tumor-free survival time is approaching 3 years. For more information, please visit: Juncell Contact: [email protected] SOURCE Shanghai Juncell Therapeutics Co., Ltd.

The 1st China anti-PD-1 monoclonal antibody successfully approved in Southeast Asia - The 1st overseas approval of HANSIZHUANG, highlighting another major milestone of Henlius' global strategy after HANQUYOU - Along with KGbio and other partners to develop and launch HANSIZHUANG in over 70 countries – SHANGHAI, Dec. 28, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius' partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia's National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the "BPOM") for the approval of Henlius' self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio for the development and commercialisation in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia. Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN 2020, there were near 35,000 new LC cases and 31,000 new deaths in 2020 worldwide, and LC is still the leading cause of cancer death [1]. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases [2]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Around 30%–40% patients are in limited stage and most patients are in extensive stage when diagnosed [3]. Their clinical condition deteriorates rapidly, and the overall prognosis is poor. In the past 20 years, chemotherapy such as etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients in extensive stage relapse within one year [4], with a median overall survival (OS) of only 10 to 11 months. The advent of immune checkpoint inhibitors has brought new hope to patients with SCLC. The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022 and became the world's first anti-PD-1 mAb for the first-line treatment of SCLC. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting over 50,000 Chinese patients. In 2022, HANSIZHUANG was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable HANSIZHUANG to benefit from certain policy support for research and development, registration, and commercialisation in the United States (U.S.) and European Union. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare HANSIZHUANG to standard-of-care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval. With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognition and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally. In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries. In 2023, the collaboration has been further expanded to 12 Middle East and North African (MENA) countries for two indications of HANSIZHUANG including ES-SCLC, covering a total of 22 emerging market countries. In the future, Henlius will work closely with KGbio and other global partners to promote approval of HANSIZHUANG in more countries. About HANSIZHUANG HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and Indonesia. Up to date, 4 indications are approved for marketing, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world. HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 3,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. SOURCE Henlius