HLX-22

SHANGHAI, Aug. 25, 2023 /PRNewswire/ -- Henlius (2696.HK) announced its 2023 interim results. In the first half of 2023, Henlius reported a boost in operating profits of RMB240.0 million and revenues of RMB2.5005 billion, up by 93.9% YoY, driven by growth in core oncology products. HANQUYOU (trastuzumab) and HANSIZHUANG (anti-PD-1 mAb) recorded sales of RMB1.2767 billion and RMB556.3 million, respectively. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 5 self-developed products have been launched, reaching more than 40 markets and benefiting over 450,000 patients. Over 10 marketing applications have been accepted for review in China, the United States (U.S.), the European Union (EU), Brazil, Canada, Indonesia, Singapore and other countries and regions. While accelerating global expansion, Henlius continues to invest in innovation with total spending on R&D hitting RMB673.8 million in the first half of 2023. Wenjie Zhang, Chairman and Executive Director of Henlius, remarked: "During the first half of 2023, Henlius achieved a rather remarkable milestone, becoming profitable for the first time in half a year. In particular, HANQUYOU and HANSIZHUANG have led to a jump in total revenue. As we progressed toward self-financing and increased momentum, we optimized our internal operations, refined our systems, and deepened our moats, thus laying the groundwork for long-term sustainable and high-quality growth to keep up in the global race." Jason Zhu, Chief Executive Officer, President and Chief Financial Officer, said: "Innovation and collaboration have allowed us to penetrate markets and expand with momentum. Moreover, lean operations have enabled us to unleash new growth opportunities and reach beyond our own borders. As we progress, we will maintain an innovative outlook and work closely with our partners to benefit patients worldwide." Global sales on an unstoppable growth streak In the first half of 2023, Henlius achieved a total sales revenue at a record high of approximately RMB2.1529 billion increased by 82.2% YoY, with its ever-increasing self-supporting capability, driving the company into a new stage of sustainable development. The company has established a professional and efficient commercial team to build a business presence in the China market and drive the market penetration on the in-house products HANQUYOU, HANSIZHUANG and HANBEITAI (bevacizumab). In the first half of 2023, these core products of the company gained sales revenue of RMB1.2767 billion, RMB556.3 million and RMB44.9 million, respectively. In addition, the company received a profit-sharing of RMB254.1 million and RMB20.8 million for HANLIKANG (rituximab) and HANDAYUAN (adalimumab) respectively. Henlius' core oncology product, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade name in Australia: Tuzucip® and Trastucip®), continues to grow at a rapid pace and achieved global sales of approximately RMB1.2767 billion in the first half of 2023, up by 57.1% YoY. Specifically, its market share has been further expanded in China. Since March 2023, the monthly sales in Chinese mainland have exceeded RMB200 million. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB1.2471 billion, representing an increase of 55.8% YoY. Overseas revenue from product sales and licensing recorded RMB32.8 million approximately, up by 120.1% YoY. Henlius has been actively promoting the global commercialization of HANQUYOU, resulting in its approval in more than 40 countries, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia, which makes it the China-developed biosimilar with the most marketing approvals. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA) and is expected to approve in the second half of the year and to further cover mainstream biopharmaceutical markets and benefit more patients around the world. HANSIZHUANG (serplulimab), the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC), has achieved total sales revenue of RMB556.3 million in the first half of 2023. Its monthly sales in Chinese mainland have exceeded RMB100 million since March 2023, a year after its launch. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). Up to date, HANSIZHUANG has completed the tendering process in 29 provinces, and was included into customized commercial medical insurance in 17 cities and provinces, benefitting over 34,000 patients. On the other hand, the New Drug Applications (NDAs) for HANSIZHUANG in the first-line treatment of esophageal squamous cell carcinoma (ESCC) has been accepted by the NMPA in China, with a decision expected in the second half of 2023. If approved, ESCC will be the fourth disease indication for HANSIZHUANG. The company also plans to submit NDA for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the second half of 2023. Furthermore, the company is advancing the commercialization of HANSIZHUANG on overseas markets at high speed. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG and is expected to be approved in the first half of 2024. The company also plans to submit BLA to the U.S. FDA in 2024. In the first half of 2023, the company continued to strengthen, broaden, and deepen its business development around the world, generating approximately RMB347.57 million in overseas licensing and other revenue, an increase of 222.5% YoY. The company joined hands with international partners such as Accord, Abbott, Boston Oncology, Getz Pharma, Elea, Eurofarma, KGbio and Fosun Pharma to accelerate overseas commercialization of products such as HANQUYOU, HANSIZHUNAG, HANLIKANG, HANDAYUAN, and HANBEITAI in countries and regions including the U.S., the EU, Brazil, Canada, Singapore, and Indonesia. In addition, the company is committed to improving the accessibility of immunotherapies and medicines for autoimmune diseases in emerging markets. During the reporting period, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. For the commercialization of HANSIZHUANG, the company expanded its collaboration with KGbio to include 12 MENA countries in addition to the previously agreed 10 ASEAN countries. R&D innovation underpinned future The first half of 2023 saw Henlius continue its differentiated innovation and R&D initiatives, exploring novel targets and molecular mechanisms in more disease areas. As the company continues to deploy its innovation centres in California and Shanghai to optimize its research layout, it also steadily expands its clinical layout worldwide. Currently, Henlius has pro-actively built a diversified and high-quality product pipeline, including over 60 molecules across monoclonal antibody (mAb), bispecific antibody (BsAb), ADC, fusion protein, and small molecule drug conjugate, of which more than 80% are self-developed. During the reporting period, Henlius is conducting over 30 clinical studies for more than 10 products globally, including 8 phase 3 clinical trials. In addition, 1 product has been granted a Breakthrough Therapy Designation (BTD) by the NMPA, 6 clinical trials have made important progress, and the Investigational New Drug Applications (INDs) for 2 potential first-in-class ADC candidates were accepted for review by the NMPA. Henlius has actively expanded its differentiated advantages for HANSIZHUANG and has launched over 10 clinical trials of combination therapy worldwide with over 3,600 subjects enrolled globally. In addition to the launched indications of sqNSCLC and ES-SCLC, Henlius also explored to treat patients with nsNSCLC and limited-stage small cell lung cancer (LS-SCLC), covering the full range of first-line treatments of lung cancers. Over 90% of lung cancer patients are expected to benefit from the therapies. Among them, the first patients in the U.S. and Australia have been dosed in an international multi-centre phase 3 clinical trial of HANSIZHUANG in LS-SCLC in January and April 2023, respectively. 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. As of now, 38 trial sites have been initiated, which is expected to accelerate the progress of the trial thus propelling the product towards US market approval. In the area of gastrointestinal cancer, the results of HANSIZHUANG for the first-line treatment of ESCC was published in Nature Medicine (IF: 82.9) and also updated at 2023 ASCO Annual Meeting. In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy. In the first half of 2023, the company continues to make every effort to promote the global multicentre phase 3 clinical studies for HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb). The first patient in the U.S. was dosed in phase 3 clinical trials of HLX04-O for wAMD in the first half of 2023. Moreover, the latest clinical results for HLX208 (BRAF V600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb) and HLX26 (anti-LAG-3 mAb) were presented to global academic community. Several potential first-in-class candidates are being fully promoted from discovery to early-stage clinical pipeline. During the reporting period, the phase 1 clinical trial for the company's self-developed HLX51, a novel humanized agonistic anti-OX40 mAb for the treatment of patients with advanced/metastatic solid tumours and lymphomas has been approved by the NMPA. Moreover, the company further strengthened its commitment in innovation and enhanced its Linker-Centric Diversified Conjugate Platforms. Utilizing the self-developed ADC platform Hanjugator, Henlius is actively pursuing clinical trial approval for HLX42 (a novel EGFR-targeting ADC) and HLX43 (a novel PD-L1-targeting ADC). Elevating quality and efficiency, steadfastly pursuing global supply Henlius has been building an integrated and comprehensive production platform to continuously improve the accessibility of its products. The current commercial production capacity is 48,000 litres, and Songjiang First Plant and Xuhui Facility have been officially put into operation, forming synergy, and developing scale effects that allow the company to supply products stably to markets beyond China, including Europe and Latin America. To further meet the global commercial production needs, the company is constructing Songjiang Second Plant, with a total capacity of 96,000 litres in the first phase. In 2026, the total production capacity is expected to reach 144,000 litres. In the first half year of 2023, Henlius made progress in lean operations and the localization of key materials and continued to evolve supply chain sustainability. The company adopted such cutting-edge technologies as Raman Spectroscopy and such system as manufacturing SCADA system. The company has always been upholding the highest quality standards, allowing its products to go global. Xuhui Facility has been certificated by China and the EU GMP while Songjiang First Plant obtained China GMP and the EU Qualified Person (QP) certification. The company's commercial production facilities and supporting quality management system have also passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. In July and August 2023, Xuhui Facility received the GMP inspection conducted by PIC/S member the Indonesian Food and Drug Authority ("BPOM") for the production line of HANSIZHUANG and Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU, respectively. Henlius has always been patient-centred and committed to addressing more unmet clinical needs. The company will continue to improve the efficiency of our business operations and innovation, strengthen partnerships with international partners, and expand its global presence in the future. 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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) 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 for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. 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

LUND, Sweden I January 2, 2023 I Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces strong interim results from the ongoing OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. This open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Within this pre-planned interim analysis for futility, data were assessed by the participating investigators and independent experts for the probability of a positive study at primary completion. The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Disease control rate, the proportion of patients with objective response or stabilization of disease, was more than 90%. These data are noteworthy, especially in the light of an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population. Safety data confirm results from the Phase 1b dose escalation phase of the trial, which showed that mitazalimab in combination with mFOLFIRINOX was safe and well tolerated at the recommended dose of 900 μg/kg. Based on these positive results, Alligator plans to initiate discussions with regulators in the US and Europe on potential accelerated development and approval pathway for mitazalimab in pancreatic cancer, while continuing patient enrolment in this ongoing trial. Top-line data from this trial are expected in Q1 2024. "We are thrilled with these interim results, which demonstrate that mitazalimab combined with chemotherapy could offer a significant clinical benefit for pancreatic cancer patients over standard of care," said Søren Bregenholt, CEO of Alligator Bioscience. "We are very keen to progress our lead asset through the next stage of its development as quickly as we can, and we look forward to discussing with regulatory authorities the potential accelerated development and approval pathway for mitazalimab in pancreatic cancer. These strong interim data reconfirm out commitment to mitazalimab and supports broadening the mitazalimab clinical development program in additional tumor types." “We are pleased with the signs of clinical activity observed in the OPTIMIZE-1 interim analysis and believe that mitazalimab in combination with chemotherapy warrants continued development for the treatment of pancreatic cancer patients, which is an area of high unmet need”, said Prof. Jean-Luc van Laethem, coordinating principal investigator, Erasmus University Hospital, Brussels (BE), “we will continue enrolment, treatment and follow-up of patients to further characterize the progression-free and overall survival, as the study continues”. [1] Conroy et al, N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923 About Alligator Bioscience Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc. Alligator Bioscience’s shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com.