Recombinant humanized anti-VEGF monoclonal antibody(Stainwei Biotech)

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

SHANGHAI, March 31, 2023 /PRNewswire/ -- Henlius (2696.HK) announced its 2022 annual results. In 2022, Henlius' revenue reached about RMB3.2147 billion, representing an increase of 91.1% YoY, primarily due to sales revenue and licensing revenue generated by the successive commercialisation of various products. As of now, Henlius has launched 5 products in China, 1 product has been approved in overseas markets, and 18 indications were approved worldwide, continuing to expand its global presence. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. In 2022, the company's R&D expenditure reached approximately RMB2.1832 billion. Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, remarked: "2022 was a milestone for Henlius, as we strive for excellence in difficult times and seek progress in stability, achieving high-quality evolution towards Biopharma. Despite the pandemic, our performance has grown against the headwinds, with revenue surpassing RMB3 billion and sales of our 5 listed products increasing rapidly, once again demonstrating our strong commercial capabilities. In addition, our business collaborations lead the nation, with multiple products licensed out and an upfront payment totaling over RMB1.5 billion. Driven by our self-developed biosimilars and innovative products, we will continue to enhance our market competitiveness for a higher-level development, growing ourselves into a leader in China's biopharmaceutical industry, and working with all circles of society to achieve greater success." A major breakthrough in commercialisation, entering a new phase of global development In 2022, Henlius has defied the impact of the epidemic and reached a sales revenue of approximately RMB2.6754 billion increased by 79.0% YoY, providing a strong impetus for R&D, manufacturing and commercialisation. By the end of December 2022, the company has established a team of over 1,000 professionals to speed up the entire commercialisation process, to build a business presence in the China market and drive the market penetration on HANQUYOU and HANSIZHUANG. In 2022, these two core products of the company gained sales revenues of RMB1.7312 billion and RMB339.1 million respectively. In addition, the company received a profit-sharing of RMB553.9 million and RMB51.2 million for HANLIKANG and HANDAYUAN respectively. Henlius' core anti-tumour product, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade name in Australia: Tuzucip® and Trastucip®), achieved a domestic sales revenue of RMB1.6959 billion, representing an increase of 95.4% YoY, overseas licensing and R&D services revenue, and sales revenue recorded RMB35.3 million and RMB168.6 million, respectively. The 150mg/60mg dual dosage and preservative-free formulation of HANQUYOU sets it apart, leading clinical practices and providing a personalized and cost-effective treatment option for breast cancer patients of any weight. On the other hand, in collaboration with Accord and other overseas commercial partners, Henlius has been actively promoting the global commercialisation of HANQUYOU, resulting in its approval in more than 30 countries, including the UK, France, Germany, Switzerland, Australia, Finland, Spain, Singapore, Argentina and Saudi Arabia. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA), which will further expand the product's footprint in major markets of biologics in the U.S. and Europe. The company's first innovative product, HANSIZHUANG (serplulimab), was launched in China in March 2022, with total sales revenue of RMB339.1 million in 9 months after launch and has been approved for 3 indications including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC) so far. As the world's first anti-PD-1 monoclonal antibody (mAb) for the first-line treatment of small cell lung cancer, HANSIZHUANG set a record for SCLC immunotherapy with a median OS (overall survival) of 15.8 months, and its international multi-centre phase 3 clinical study ASTRUM-005 was published in the top medical journal JAMA (impact factor 157.3). The company has been pushing forward the global commercialisation of HANSIZHUANG to bring benefits to more patients and it was granted orphan drug designations by the European Commission (EC) and the U.S. FDA for the treatment of small cell lung cancer. As of now, the European Medicines Agency (EMA) has validated the Marketing Authorization Application(MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC. Henlius also plans to submit a BLA for HANSIZHUANG in the U.S. in 2024. In addition, a New Drug application (NDA) for HANSIZHUANG for the first-line treatment of esophageal squamous cell carcinoma (ESCC) has been accepted by the NMPA in China, and the results of the study ASTRUM-007 were published in Nature Medicine (impact factor 87.2). In 2022, the company made a new high in business collaboration and obtained overseas licensing and other revenue of approximately RMB539.3 million, representing an increase of 188.3% YoY. The company joined hands with international partners such as Organon, Abbott, Getz Pharma, Eurofarma and Fosun Pharma to accelerate overseas commercialisation of products such as HANSIZHUNAG, HANQUYOU, HANLIKANG, HANDAYUAN, HANBEITAI, HLX11, HLX14, etc. The upfront payment for overseas licensing revenues in 2022 totaled RMB1.5 billion, with a potential transaction amount of up to US$1.446 billion. Among which, the company sealed a deal with Organon for two biosimilars in development and is expected to receive up to a total of US$541 million, including an upfront payment of US$73 million, which marks the largest biosimilar licensing deal in the past five years. The company also entered into an exclusive license agreement with Fosun Pharma for commercialisation of HANSIZHUNAG in the U.S. with RMB1 billion of upfront payment, breaking into the U.S. biopharma market. Enable differentiated innovation with global clinical data In 2022, Henlius continued to broaden and deepen product innovation, commit greater resources to R&D pipeline with innovation product as a core, and consolidate the construction of R&D platforms such as antibody-drug conjugates (ADC) platforms. The pipeline cuts across a wider range of therapeutic areas and molecule types including bispecific antibodies and ADCs. The company initiated more than 30 clinical trials in China, the U.S., the EU, Australia and other countries and regions, with 16 new clinical trials approved and 15 first patient dosing completed in the year. Along with the rapid commercialisation of HANSIZHUANG, the company is actively expanding its differentiation advantages to cover a wide range of high-incidence tumour types, including lung cancer and gastrointestinal cancer, and has enrolled more than 3,500 patients worldwide. It made breakthroughs and won recognitions from global academics. In 2022, Henlius explored more on HANSIZHUANG in wider population and more regions across the world. The first patient has been dosed in an international multi-centre phase 3 clinical trial (ASTRUM-020) of HANSIZHUANG in patients with limited-stage small cell lung cancer (LS-SCLC) in the U.S. Another patient has also been dosed in a head-to-head bridging trial of HANSIZHUANG versus first-line standard of care atezolizumab for ES-SCLC in the U.S, which propels the product towards U.S. market approval further. In addition, the company continues to explore the combination therapies between HANSIZHUANG and self-developed products such as HANBEITAI, HLX07 (anti-EGFR mAb), HLX26 (anti-LAG-3 mAb), HLX208 (BRAF V600E small molecule inhibitor) and HLX60 (anti-GARP mAb) to further maximize the anti-tumour synergy effect. In 2022, Henlius has been unlocking the potential of the candidate targets including BRAF, LAG-3, TIGIT, 4-1BB, GARP and OX40, and joined forces with global partners to build global presence and open more markets. The company accelerated the international multi-centre Phase 3 clinical studies of HLX11(biosimilar to Pertuzumab), HLX14(biosimilar to Denosumab) and HLX04-O (anti-VEGF mAb), and completed the first-patient dosings in China, the U.S., the EU, Australia and other countries and regions. The company also enriched its early-stage pipeline by licensing-in, entering into strategic collaborations with Novacyte Therapeutics Biomedical Technology, Palleon and MediLink Therapeutics to further strengthen competitiveness in the global oncology therapeutics. Enhance quality and efficiency to improve the integrated production platform In 2022, the company's commercial production capacity doubled to 48,000 litres. The three production facilities, Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, can altogether reach a larger operational scale with the total commercial production capacity expected to reach 144,000 litres in 2026. In 2022, Songjiang First Plant was put into commercial operation and its 24,000 litres can be fully used for the commercial production of HANQUYOU, which offered a strong support for its market expansion. In 2022, Songjiang First Plant obtained China GMP and EU Qualified Person (QP) certification and is expected to receive FDA GMP inspection in 2023. To secure more commercial production in the long run, the construction of Songjiang Second Plant is underway, with its first stage well on track and the first engineering run to be completed in 2023. Moreover, Henlius continues to promote lean manufacturing to improve production efficiency, drive cost reduction and reinforce the localization of key materials and equipment, by for example exploring the control system for large-scale stainless steel bioreactors. Looking ahead, Henlius will continue to bolster up its commercialisation, keep improving the efficiency of innovation, and optimize the long-term planning of three manufacturing facilities to evolve towards a sustainable Biopharma with sharpened edges in R&D, manufacturing and commercialisation to bring more and better treatment options to patients worldwide. 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 commercialisation. 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