On November 15, 2023 Henlius（2696.HK）reported its financial results and business update for the first three quarters of 2023 (Press release, Henlius Biopharmaceuticals, NOV 15, 2023, View Source [SID1234637718]). As of September 30, 2023, Henlius generated a total revenue of RMB3.9278 billion, rising by 84.0% YoY, and a profit totaled RMB407.8 million, attributed to the highly efficient commercial operation and successive growth in core products. Among which, HANQUYOU (trastuzumab, trade name in Europe: Zercepac, trade names in Australia: Tuzucip and Trastucip) and HANSIZHUANG (serplulimab) gained sales revenues of RMB2.0145 billion and RMB865.4 million, respectively.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biologic medicines to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 self-developed products have been launched, benefiting over 495,000 patients and reaching more than 40 markets. Over 10 marketing applications have been accepted for review in the European Union (EU), the United States (U.S.), Canada, Brazil, Columbia, Indonesia, Singapore and other countries and regions.
Wenjie Zhang, Chairman and Executive Director of Henlius, said: "During the first three quarters of 2023, Henlius delivered strong financial report, our integrated biopharmaceutical platform was further validated while the commercialisation potential gradually being unlocked. As we maximised the value of our products and continued our growth momentum, we have also strengthened our internal operations and management to enhance the foundations of high-quality development, working together to build a more valuable global biopharma."
Jason Zhu, Chief Executive Officer, President and Chief Financial Officer, said: "In 2023, we continued to address unmet clinical needs worldwide, and our strategy of innovation and globalisation has yielded remarkable results. Looking forward, we will adhere to our mission and fortify our core competencies, providing high-quality and accessible biologics to patients around the world."
Keep robust momentum of commercialisation, actively expand global footprint
In the third quarter of 2023, Henlius has maintained a positive growth momentum through the fast market penetration of its core products and achieved remarkable milestones, reaching a sales revenue of approximately RMB1.2256 billion. HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB737.8 million, RMB309.1 million and RMB36.4 million, respectively. In addition, the company received a profit-sharing of RMB131.0 million and RMB11.3 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.
Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefitting about 155,000 Chinese patients. Following the acceptance of the biologics license application (BLA) by the U.S. Food and Drug Administration (FDA), the Health Canada accepted the New Drug Submission (NDS) of HANQUYOU in July 2023. As of now, HANQUYOU has been launched in more than 40 countries, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia, making it the China-developed biosimilar with the most marketing approvals.
HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). Since its launch in March 2022, HANSIZHUANG has earned wide recognitions and has seen rapid sales uptick with its breakthrough efficacy and differentiation advantages in the relevant treatment fields，benefitting about 43,000 Chinese patients. In September 2023, HANSIZHUANG has been approved for the first-line treatment of esophageal squamous cell carcinoma (ESCC), took a step forward in the company’s layout in the field of treatment of gastrointestinal tumours. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and ESCC. Henlius also plans to submit New Drug Application (NDA) for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the fourth quarter of 2023.
In 2023, Henlius has yielded remarkable results in global development and obtained new opportunities for growth. During the reporting period, the company earned approximately RMB546.7 million in overseas licensing and R&D services revenues, increasing by 232.1% YoY. Henlius deepened collaboration with partners to expand the global coverage of HANSIZHUANG. In September 2023, Henlius extended its collaboration with KGbio, the current partner on HANSIZHUANG in 10 ASEAN member countries, on the exclusive rights to develop and commercialise HANSIZHUANG in 12 Middle East and North African (MENA) countries. Henlius further expanded its collaboration with Intas in October 2023 to grant the company exclusive rights to develop and commercialise HANSIZHUANG in Europe and India, with a potential value of EUR€185 million.
Bolster competitiveness with relentless innovation and high quality
Henlius continued its differentiated innovation and R&D layout, speeded up the innovation progress by strengthening internal innovation capabilities and external collaboration. 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.
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 the field of lung cancer treatment, the phase 3 clinical study of HANSIZHUANG as a first-line treatment for patients with advanced nsNSCLC has met the primary endpoint. While the first subjects have been dosed in two clinical trials including the international phase 3 clinical study of HANSIZHUANG in combination with chemotherapy and concurrent radiotherapy for the treatment of LS-SCLC, as well as the phase 2 clinical trial of HLX26 (anti-LAG-3 mAb) in combination with HANSIZHUANG and chemotherapy for the first-line treatment of advanced NSCLC. What’s more, the phase 1/2 clinical trial of HLX04-O was completed in patients with wet age-related macular degeneration (wAMD) in July 2023.
Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, pursuing clinical trial approvals for a couple of potential first/best-in-class products. In October 2023, the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43 have been simultaneously approved by the National Medical Products Administration (NMPA), for the treatment of advance/metastatic solid tumours. And the results of the non-clinical studies of these two ADC candidates debuted at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
In 2023, Henlius continues to improve its production capacity and accessibility of the company’s products based on an integrated production platform, as well as a sound quality management system. The current commercial production capacity is 48,000 litres, forming synergy, and developing scale effects that allow the company to supply products stably to markets beyond China, including Europe and Latin America. Henlius is also constructing Songjiang Second Plant to further meet the global commercial production needs, with the total production capacity expected to reach 144,000 litres in 2026. In addition, the company has always been upholding the highest quality standards, allowing its products to go global. As of now, Henlius’ 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. Among which, 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. In July 2023, Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU. In August 2023, Xuhui Facility has undergone the on-site GMP inspection conducted by Health and Youth Care Inspectorate (a health supervision agency in the Netherlands) for HANSIZHUANG before launch in EU, and part of Songjiang First Plant has also undergone the GMP extended inspection. In October 2023, Xuhui Facility successively passed the GMP Inspections for HANSIZHUANG by PIC/S Member Indonesia BPOM, and for HANLIKANG and HANQUYOU by PIC/S Member Brazil ANVISA.
Committed to meeting unmet medical needs, Henlius will further solidify its industry-leading capabilities in "integrated research, manufacturing and commercialisation", consistently invest in innovation and foster global collaboration. By doing so, the company aims to evolve into a higher-value global biopharmaceutical, providing more affordable and better therapies for patients worldwide.