Part of shanghai fosun new drug research co., ltd.
Fuhong Hanlin (2696.HK) is an international innovative biopharmaceutical company committed to providing high-quality and affordable innovative biopharmaceuticals to patients around the world. Its products cover the fields of tumors, autoimmune diseases, eye diseases, etc. Since its establishment in 2010, Fuhong Hanlin has built an integrated biopharmaceutical platform, and its independent core capabilities of efficiency and innovation span the entire R&D, production and commercial operation industry chain. The company has R&D centers in Shanghai, China and California, where production and quality control are carried out in accordance with international GMP standards. The production base in Xuhui, Shanghai has obtained GMP certification from China and the European Union. Under the company's mission and vision, Fuhong Hanlin brought together a group of outstanding experts with rich industry experience in drug research and development, clinical, production, commercialization, pharmaceutical administration affairs, CMC, quality and compliance for leading multinational pharmaceutical companies. In 2016, Fu Hong Han Lin built a biopharmaceutical production base with disposable bioreactors and other equipment as the core technology in the Caohejing New Technology Development Zone in Shanghai. Currently, the quality management system supporting the base has passed a number of on-site inspections or audits carried out by the China Drug Administration, the European Medicines Administration, the EU Quality Authorized Person (QP) and international business partners, and has obtained Chinese and EU GMP certifications. In order to further improve the production capacity plan, Fuhong Hanlin also invested in the establishment of a biomedical industrialization base in the Songjiang district of Shanghai. Among them, the Songjiang base (1) plans to build a production capacity of 24,000L and has now begun GMP production of clinical samples; the Songjiang base (2) covers an area of about 200 acres. After completion, it will become a large-scale biomedical production base in China, which can meet the simultaneous production of more than 20 products after being fully put into operation. The base was designed in strict accordance with international GMP standards, making full use of new international technologies such as single-use production technology and continuous flow production technology. The structural capping of the main production building has now been completed. Fuhong Hanlin has prospectively laid out a diversified, high-quality product pipeline, covering more than 20 innovative monoclonal antibodies, and comprehensively promoting tumor immunotherapy based on its own anti-PD-1 monoclonal antibody HLX10. Up to now, the company has successfully launched 3 products — the first domestically produced biosimilar drug Hanlikon (rituximab); the first Chinese and European batch of domestic single-antibiotic analogue Hantriumab (trastuzumab, EU trade name: Zercepac); and the company's first autoimmune disease treatment product, Handazumab (adalimumab). Among them, Han Quyou pioneered the participation of Chinese pharmaceutical companies in the single-antibiotic “World Cup” competition, which is expected to bring more treatment options to patients with HER2-positive breast cancer and stomach cancer around the world. In addition, the marketing registration applications for HLX04 bevacizumab and HLX01 rituximab for new indications for rheumatoid arthritis are being reviewed. The company is also simultaneously conducting more than 20 clinical trials on 10 products and 8 combination treatment plans worldwide, covering all mainstream European and American biopharmaceutical markets and markets in many emerging countries.
Clinical Trials
36
18 active
Approvals
3
Total approvals
Agencies
1
Regulatory bodies
Founded
2010
Active, not recruiting
13
36.1%
Not yet recruiting
5
13.9%
Recruiting
7
19.4%
Unknown
11
30.6%
- Sandoz will hold exclusive global commercialisation rights to a proposed emicizumab biosimilar, excluding Argentina, Uruguay and Paraguay, while mAbxience handles development and manufacturing. - The reference medicine Hemlibra (emicizumab) treats haemophilia A and generated an estimated USD 5.7 billion in global sales, making it the first haemophilia asset in Sandoz's biosimilar pipeline. - The deal lifts the Sandoz biosimilar pipeline to 40 assets and follows earlier agreements with Henlius for up to 10 assets and Samsung Bioepis for up to five. - Haemophilia A is a rare genetic disorder caused by inadequate or defective factor VIII and accounts for roughly 80% of all haemophilia cases, with more than half of patients having the severe form.
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- Henlius reported first-half 2026 revenue of RMB 3.5882 billion, up 27.3% year-over-year, with net profit of RMB 430.4 million, up 10.3%. - Serplulimab received NMPA approval in June 2026 as the world's first and only anti-PD-1 monoclonal antibody for perioperative gastric cancer treatment. - Ex-China product sales surged 159.4% year-over-year to RMB 105.3 million, reflecting accelerating global commercialization under the company's Globalization 2.0 strategy. - R&D expenditure rose 45.7% to RMB 1.4507 billion, advancing a differentiated pipeline including the PD-L1 ADC HLX43 and anti-HER2 mAb dulpatatug.
- Henlius presents the design of HLX22-GC-301, an international Phase 3 head-to-head trial comparing HLX22 plus trastuzumab against current standard of care for HER2-positive gastric cancer. - The novel anti-HER2 monoclonal antibody HLX22 binds to a different epitope than trastuzumab, enabling simultaneous binding and resulting in 40-80% increased HER2 internalization. - Phase 2 data showed median overall survival was not reached with HLX22 combination versus 16.4 months for control, with an 80% reduction in disease progression risk. - The Phase 3 trial will enroll approximately 550 patients globally without PD-L1 expression restrictions, aiming to redefine first-line treatment for HER2-positive gastric cancer.
- Genentech and Roche obtained ex-parte orders from the Brussels Local Division to inspect Organon's manufacturing facilities in the Netherlands and Belgium for evidence of patent infringement related to their breast cancer drug Perjeta. - The dispute centers on patent EP 2238172 protecting pertuzumab, a $4.4 billion anti-HER2 antibody, with Organon planning to launch a biosimilar after receiving EMA marketing authorization. - The court authorized broad evidence collection with €200,000 penalties for non-compliance, marking a significant adoption of UPC evidence gathering tools by pharmaceutical companies. - This case represents the first major pharmaceutical patent enforcement action using UPC inspection procedures, previously utilized only for other industries like heavy machinery.
- Henlius Biotech's PD-1 inhibitor serplulimab achieved its primary endpoint in a Phase 3 trial for perioperative gastric cancer treatment, potentially becoming the first immunotherapy to replace adjuvant chemotherapy in this indication. - The company reported strong financial performance with RMB 2.8 billion in revenue and RMB 390 million in net profit for the first half of 2024, while overseas profits surged 200% year-over-year. - Serplulimab generated RMB 1.31 billion in global sales in 2024, representing over 20% of total revenue, with the company estimating peak sales potential of USD 5 billion globally. - Henlius has successfully launched nine products worldwide across 60 countries, treating over 900,000 patients, with promising pipeline candidates including HLX43 ADC and HLX22 for HER2-positive gastric cancer.
- Shanghai Henlius Biotech announced that HANSIZHUANG (serplulimab) plus chemotherapy met the primary endpoint of event-free survival in the phase 3 ASTRUM-006 trial for perioperative gastric cancer treatment. - The study achieved a more than threefold higher pathological complete response rate compared to placebo plus chemotherapy, representing the world's first regimen to replace adjuvant chemotherapy with mono-immunotherapy. - The breakthrough enables early NDA submission and offers a "chemotherapy-free" adjuvant approach that maintains efficacy while improving patient quality of life. - Gastric cancer affects approximately 969,000 new patients worldwide annually, ranking fifth in both cancer incidence and mortality according to GLOBOCAN statistics.
- Henlius' investigational antibody-drug conjugate HLX43, targeting PD-L1, has been granted Orphan Drug Designation by the U.S. FDA for treating thymic epithelial tumors. - The drug combines a novel DNA topoisomerase I inhibitor with Henlius' self-developed PD-L1-targeting antibody and is currently in Phase I clinical trials across China, the United States, and Japan. - HLX43 represents a first-in-class approach, as no antibody-drug conjugates targeting PD-L1 have been approved for marketing globally. - The company has also received NMPA approval to test HLX43 in combination with HLX07, an anti-EGFR monoclonal antibody, for advanced solid tumors.
- Henlius has dosed the first patient in a Phase 2 clinical trial evaluating HLX79, a potential first-in-class human sialidase enzyme therapeutic, combined with rituximab for active glomerulonephritis treatment. - The double-blind, randomized, controlled trial will assess the safety, tolerability, and efficacy of HLX79 at doses of 10-30 mg/kg combined with rituximab in patients with lupus nephritis and membranous nephropathy. - HLX79 works through glyco-immunology by degrading sialic acid to enhance clearance of pathogenic immune cells, potentially addressing inadequate responses to current rituximab monotherapy. - China accounts for nearly 30% of global end-stage renal disease cases with approximately 3.5 million patients, representing a significant unmet medical need in glomerulonephritis treatment.
- China has emerged as a significant player in global drug development, accounting for 23% of global drug candidates in 2024, creating new pathways for translational research in the US. - Chinese biotech companies can progress from launch to first-in-human data in just 18 months compared to several years in the US, raising questions about transcontinental applicability of clinical data. - Innovative "bridging studies" are becoming crucial for demonstrating the translatability of China-developed drugs to Western populations, requiring diverse patient enrollment and pharmacokinetic similarities across ethnic groups.
