Bevacizumab biosimilar(Shanghai Henlius)

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. This press release features multimedia. View the full release here: The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint of this study was the percentage change in bone mineral density (BMD) at the lumbar spine from baseline to Week 52 (D365) assessed by central imaging. The primary pharmacodynamic endpoint was the area under the effect–time curve for percentage change of serum type I collagen C-telopeptide (s-CTX) from baseline to Week 26 (D183) (AUEC0–26W). The primary endpoints of this study were met. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. 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, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 7 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 Facility and Songjiang First Plant, both certificated by China and the EU 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 for injection, trade name in Europe: Zercepac®), 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 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. To learn more about Henlius, visit or connect with us on LinkedIn at . About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding Organon’s license and supply agreement with Henlius. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on Organon’s current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon’s plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect Organon’s future results include, but are not limited to, our inability to successfully commercialize products in our biosimilars portfolio, the performance, operations and regulatory compliance of Henlius and its suppliers, efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures or regulatory developments, that adversely impact demand for, availability of, or patient access to Organon’s products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( ). View source version on businesswire.com: Contacts Organon Media Contacts: Karissa Peer (614) 314-8094 Hannah Silver (917) 509-8864 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Alex Arzeno (203) 550-3972 Henlius Media Contacts Bella Zhou wenting_zhou@henlius.com Janice Han jiayi_han@henlius.com Source: Organon & Co. View this news release online at:

SHANGHAI, March 21, 2024 /PRNewswire/ -- Henlius (2696.HK) announced its 2023 annual results. During the reporting period, Henlius' revenue reached about RMB5.3949 billion, representing an increase of 67.8% YoY, and recorded a net profit of RMB546.0 million. This is the first time for Henlius to achieve full-year profits following the company's achievement of its first half-year profits in H1 2023. The full year of profitability is due to increasing commercial sales of the core products and expanding sales volume. Henlius' products achieved total sales of approximately RMB4.5535 billion in 2023, up by 70.2% YoY. Up to date, Henlius has 5 products launched in China, 2 launched in overseas markets, 19 indications approved worldwide, benefiting over 560,000 patients and reaching more than 40 markets in Asia, Europe, Latin America and Oceania. Besides, over 50 marketing applications of its products have been accepted for review in countries and regions including China, the EU, the U.S., Canada, Singapore and Thailand. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. In 2023, the company's R&D expenditure reached approximately RMB1.4336 billion. Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius achieved remarkable performance and recorded full-year profits for the first time. Through unwavering innovation and outstanding execution, we have established a solid foundation for high-quality development and have been continuously improving the efficiency of our integrated biopharmaceutical platform, enabling the company to accelerate its development. Furthermore, we've boosted efficiency in operations and management across the business, driving steady and strong growth and inspiring us to build an innovative global biopharmaceutical company with high-quality development." Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: "Under the dual-drive strategy of 'biosimilars and novel biologics', Henlius continues to accelerate both domestic and overseas market expansion, stick to lean operations, promote high-quality and synergistic product development, increase profitability and further advance its comprehensive capabilities. In the future, we will adhere to patient-centricity, further optimize our innovation layout, expand the global distribution of high-quality biological drugs, and make greater contributions to improving human health and well-being." Achieving strong growth in commercial performance and making new breakthroughs in overseas expansion In 2023, Henlius has made achievements in product commercialization, business models construction, market layout optimization and overseas market expansion. Its five products achieved total sales revenue of approximately RMB4.5535 billion. HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB2.7370 billion, RMB1119.8 million and RMB119.4 million, respectively. In addition, the company received sales revenues of RMB540.5 million and RMB58.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively. Henlius' core oncology product HANQUYOU continues to unleash strong growth momentum. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB2.6444 billion, up by 56.1% YoY. Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefiting over 180,000 Chinese patients to date. Overseas revenue from product sales recorded RMB92.6 million approximately, up by 162.3% YoY. As one of the pioneers of domestic biopharmaceuticals going global, HANQUYOU has successfully been approved for marketing in over 40 countries and regions, including the United Kingdom, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, etc., becoming the China-developed biosimilar with the most marketing approvals. Meanwhile, the product's accessibility has been further improved. It is now reimbursed nationally in countries including China, the UK, France, and Germany. In 2023, the overseas commercialization of HANQUYOU managed to include the markets of Thailand, the Philippines and Brazil, and its marketing applications in the United States and Canada have also been accepted and expected to be approved for marketing in 2024. Henlius' innovative product HANSIZHUANG, the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China and Indonesia. In 2023, HANSIZHUANG has recorded a total sales revenue of RMB1119.8 million, representing an increase of 230.2% YoY. Up to now, it has been approved for 4 indications and in 2023, it was approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC), benefiting over 60,000 Chinese patients to date. Additionally, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). On the other hand, Henlius continues to expand HANSIZHUANG's global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. Furthermore, the company submitted marketing applications for HANSIZHUANG in Thailand, Singapore, Malaysia to further promote the product in Southeast Asia. In March 2023, HANSIZHUANG's Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging 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 to further support the Biologic License Application (BLA) in the U.S. Henlius is also advancing HANSIZHUANG-based tumour immuno-combination therapies and has initiated over 10 clinical trials worldwide. In 2023, the company achieved a number of milestones in business development, boosting new vitality in global expansion for its products. During the reporting period, Henlius earned approximately RMB841.4 million in overseas licensing and other revenues, an increase of 56.0% YoY. In 2023, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. Moreover, the company expanded its collaboration with KGbio to commercialize HANSIZHUANG in 12 MENA countries. It also deepened collaboration with Intas to commercialize HANSIZHUANG in over 50 countries in Europe and India. Up to now, the company has collaborated with international partners such as Accord, Abbott, Eurofarma, Elea and KGbio to globalize its 8 products including HANLIKANG, HANQUYOU and HANSIZHUANG, covering mainstream biopharmaceutical markets in Europe, the United States, and numerous emerging markets, further expanding its global presence. Charting innovation and improving global supply with enhanced quality and efficiency As an innovative global biopharma company, Henlius has always been guided by clinical needs and collaborated with its global innovation centres and product development teams to continuously boost innovation and build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market. Currently, its product pipeline covers more than 50 molecules including mAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, and has conducted over 30 clinical studies for 16 products worldwide. In 2023, the company has accelerated many international multi-centre phase 3 clinical researches of HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with plans to submit marketing applications worldwide in 2024. On the other hand, the latest clinical results for HANSIZHUANG, HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb), HLX26 (anti-LAG-3 mAb), HLX42（EGFR ADC）and HLX43（PD-L1 ADC）have been presented to global academic community, including Nature Medicine, Cancer cell, 2023 ASCO, 2023 ESMO, 2023 ESMO Asia and gained wide recognition. Moreover, the company is actively exploring novel targets and mechanisms, constantly expanding into more disease areas and molecular types, so as to accelerate the development of innovative medicines to address complex diseases. Henlius is promoting a number of potential first/best-in-class products, including HLX42 , HLX43 , HLX6018 (anti-GARP/TGF-β1 mAb) and HLX99 (polypharmacology) to enter into clinical/clinical registration filing stage. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products. The company is also accelerating the introduction of innovative products that have multiplier effects with its existing pipeline to drive growth, and has recently acquired the China rights of a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global phase 3 clinical development, bringing more effective and targeted solutions to more patients. In 2023, Henlius continued building an integrated and comprehensive production platform, enhancing its global supply system to support the company's worldwide commercial layout and to provide inclusive healthcare for patients. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current commercial capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2023, the Songjiang Second Plant completed the construction and validation of two major buildings and the first engineering run. Henlius benchmarks the highest international standards to construct its quality management system. It has passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. Both Xuhui Facility and Songjiang First Plant have been granted with China and the EU GMP certificates. In 2023, the company's manufacturing facilities successively obtained GMP certificates from PIC/S member Indonesia and Brazil for products including HANQUYOU, HANSIZHUANG, and HANLIKANG, and were granted EU GMP certificate for the production lines of HANSIZHUANG. Additionally, the Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU. Adhering to patient-centricity, Henlius will further strengthen its commercialization capabilities as a biopharma, deepen its global strategic presence, drive high-quality innovation, and continue to improve the quality and efficiency of its manufacturing operations, so as to achieve a leap from rapid growth to high-quality development, enabling more high-quality innovative outcomes to benefit more 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, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 7 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 Facility and Songjiang First Plant, both certificated by China and the EU 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 for injection, trade name in Europe: Zercepac®), 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 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