Benmelstobart

VANCOUVER, Washington, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Dear Shareholders, As this pivotal year continues to take shape for CytoDyn Inc. (“CytoDyn” or the “Company”), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evidence. From laboratory insights to encouraging patient survival observations, our story is compelling and one of consistent validation. The data presented over the past several months marks a watershed moment for both patients and our Company, providing evidence that leronlimab has the potential to reshape treatment paradigms in solid tumor oncology. With multiple clinical trials advancing, we are moving with discipline and urgency along a well-defined path forward. Strengthening Our Leadership To support this next chapter, we welcomed Robert E. Hoffman as our new Chief Financial Officer. An industry veteran with decades of financial and leadership experience, holding various executive and board positions in his biotech career, Robert has already brought significant value to CytoDyn. His expertise in capital markets and strategic planning strengthens our ability to execute, network, and expand our pipeline. We are delighted to have him aboard. Scientific Progress and Clinical Development At the heart of leronlimab’s promise is a novel mechanism of action (“MOA”) associated with prolonged survival observed in a group of patients with Metastatic Triple-Negative Breast Cancer (“mTNBC”). Supporting data, presented at a poster session at the European Society for Medical Oncology (“ESMO”) breast cancer meeting in Munich, suggest that leronlimab induces PD-L1 expression, creating synergy with immune checkpoint inhibitors (ICIs), a potential breakthrough in solid tumor treatment. This finding not only opens new therapeutic opportunities for leronlimab, but also represents a significant market opportunity for the Company. For additional information on this novel MOA and the status of our clinical initiatives and publications, please see the science update included with this letter. One indication that carries the potential for significant value return is leronlimab in mTNBC, the most aggressive form of breast cancer, with 5-year survival rates around 15%. Based on the positive data presented at ESMO, we will shortly submit a follow-up Phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. These patients, currently ineligible for ICI therapy, will receive leronlimab plus standard chemotherapy, followed by a regimen of leronlimab with an ICI. We look forward to sharing more details after the FDA review of the protocol and briefing package that provides a complete summary of CytoDyn’s oncology data. In parallel, we will be submitting an Expanded Access Protocol (“EAP”) to enable treatment for patients with second-line, or later, mTNBC, who are ineligible or otherwise unable to participate in our Phase II study. I am pleased to announce that we will be working with an individual benefactor to fund the launch of this compassionate-use program. This benefactor has also expressed interest in supporting an investigator-initiated study in patients with recurrent glioblastoma with an anticipated start date in 2026. Beyond breast cancer, leronlimab continues to advance in the treatment of metastatic Colorectal Cancer (mCRC). Enrollment in our Phase II study is underway with five sites initiated and several more onboarding in the next several weeks. The enrollment of our fifth patient in the trial will trigger the Data Safety Monitoring Board (DSMB) safety review, which could then open study randomization to include the 700 mg dose. Importantly, we will be closely tracking PD-L1 levels of enrolled patients to further validate our MOA across solid tumors. With that in mind, we have prepared a rollover protocol to ensure that CRC patients who remain stable can continue leronlimab treatment beyond 48 weeks and to allow patients with disease progression the opportunity to receive leronlimab at a dose of 700 mg in combination with an ICI. Finally, I am happy to share a very promising announcement as it relates to a patient who prospectively upregulated PD-L1 after having obtained access to leronlimab through an eIND application submitted by her treating physician. In early 2025, we received a compassionate access request for a patient with mTNBC who was previously unresponsive to treatment with Keytruda. This particular patient had two prior tissue biopsies, both of which were PD-L1 negative. In April, the patient started treatment with leronlimab, and in July blood tests confirmed an increase in PD-L1 levels. Our past clinical observations have shown that upregulating PD-L1 is the first step towards prolonged survival in this patient population and we are encouraged by this readout, which supports our working theory. This is the first of hopefully many PD-L1 upregulation readouts across our CRC and TNBC trial(s) in the coming year. I continue to have high hopes for our upcoming Phase II trials, as well as our expanded access program, as we look to reshape treatment paradigms in solid tumor oncology. Update on Regulatory Matters, Resolution of SEC and DOJ Investigations I am also pleased to share that we recently received confirmation from both the Securities and Exchange Commission (“SEC”) and Department of Justice (“DOJ”) that their respective investigations have now closed, and nothing further is required of the Company. I believe this positive conclusion for the Company is a reflection of our team here and our collective commitment to compliance and cooperation. I remain confident that our collaborative relationship with the FDA has placed us on a productive trajectory. To accelerate progress in oncology, we established an oncology advisory board focused on pursuing the fastest and most responsible pathway(s) forward. The FDA recently granted our request for a meeting, and we look forward to discussing our retrospective data set and related observations in TNBC, as well as the next steps in our TNBC development plan. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we move forward. Commitment to our Shareholders Your support has carried the Company through the last several years and we remain committed to acting in your best interests. I want to thank you all again for your perseverance and patience. Your questions and feedback are always appreciated and best received through the Company’s IR email account: ir@cytodyn.com. In the coming months, we will be engaging in critical conversations with our key opinion leaders, potential industry partners and regulators. In support of these efforts, we ask our shareholders to be mindful of the process and respectful of our counterparties. Excessive outreach to these third parties can inadvertently hinder our progress. Our recent results and the novel MOA have attracted the attention of numerous patients, treating physicians, and others across the industry. Please know that we are actively pursuing collaborations to maximize the potential of leronlimab. A Human Reminder of Our Mission In closing, I’d like to share a brief personal anecdote. As the Company has worked to confirm the mTNBC survival observations and arranged for related follow-up testing, I’ve had the opportunity to speak with several of the surviving patients who accessed leronlimab during the Company’s prior oncology studies. These are individuals who had exhausted all other options yet are now enjoying more time with their families. I had the privilege of sharing a meal with one survivor and her spouse and it is difficult to put into words the emotions we all felt when reflecting on the remarkable sequence of events that brought us together that night, but I can name the most prominent – hope. Encounters like these remind us why our work matters and fuel our determination to accelerate progress for patients everywhere. With Gratitude, Jacob Lalezari, MDCEO Note Regarding Forward-Looking Statements This news release contains forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments other than as required by law. Corporate Contact CytoDyn Inc.ir@cytodyn.com Media ContactsRob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.Russo Partners, LLCCytoDyn@russopartnersllc.com Science Supplement – September 2025 – History of leronlimab in mTNBC Dr. Richard Pestell, our Lead Consultant – Preclinical and Clinical Oncology, has published preclinical data demonstrating that leronlimab both prevented the metastatic spread of TNBC and caused reversal of established metastases in mice. These important observations speak to two different mechanisms by which leronlimab's blockade of the CCR5 receptor appears to impact cancer: the first involves the role that CCR5 plays in cell migration and how that receptor is hijacked by cancer cells to promote the spread of distant metastases; the second speaks to the direct anti-cancer activity of leronlimab on an established tumor itself and, in particular, the surrounding microenvironment. To follow up on these preclinical observations, CytoDyn conducted three clinical studies in patients with mTNBC and other solid tumors starting in 2019. Analysis of pooled follow-up data from the 28 patients with mTNBC enrolled across these studies formed the basis for our presentation at ESMO and provided evidence of leronlimab’s stand-alone activity in three important ways: Promising survival rates: Overall survival rates at years 1, 2, 3, and 4 (35.7%, 21.4%, 17.9%, and 17.9%) compare favorably with previous studies of patients with advanced mTNBC. In particular, the long-term survival rates of 17.9% at both years 3 and 4 are very exciting, considering other studies exploring potential mTNBC treatments typically don’t even report survival rates out to three years. Moreover, the survival rate of 17.9% at year 4 was calculated without removing or “censoring” patients who dropped out for any reason, meaning it is presented in the most conservative way possible. Impact on advanced disease: Patients in our study population had failed a median of two prior lines of treatment after developing metastatic disease, and a majority had cancer in other organs (64% had visceral metastases and 29% had brain metastases at entry into the studies). Despite that, the median overall survival (“mOS”) of 6.8 months for all 28 patients (9.7 months for the 18 patients receiving > 525 mg) appears comparable to the current standard of care. This makes our results especially promising, given our study population had, generally speaking, more advanced disease than typical clinical populations. Given our survival observations and working theory on the mechanism of action, we are excited to explore leronlimab as an earlier line of therapy with the idea that earlier treatment could serve to save more lives. Decreased CTC levels: The decline in circulating tumor cells (“CTCs”) observed in most patients after as little as one dose of leronlimab was significantly associated with both progression-free and overall survival. Leronlimab’s rapid and prognostically significant impact on CTCs, which appears to reflect activity within the primary tumor itself, provides important evidence of leronlimab’s activity as a stand-alone agent. Confirming the full extent of leronlimab’s activity on the primary tumor is on our short list of clinical priorities in the coming months. CytoDyn’s Presentation at ESMO – Outlining a Novel Mechanism of Action As announced leading up to the ESMO presentation, the survival observations and related retrospective data collectively suggest a potential paradigm shift in solid tumor oncology involving leronlimab’s novel mechanism of action in conjunction with Immune Checkpoint Inhibitors (“ICIs”). To help understand this new paradigm, the following is an explanation of the basic steps and the Company’s working theory at this time: For a cancerous tumor to establish itself and grow in the body, it attempts to avoid detection and an immune response. One way a cancer can do this is by hijacking CCR5, a protein receptor on the surface of certain immune cells. Through CCR5 signaling, the tumor commandeers host macrophages, a type of white blood cell that would otherwise attack the cancer cells, to help the tumor build a surrounding area or “microenvironment” to support its growth, including a blood supply that provides necessary nutrients. The growing tumor also uses CCR5 signaling to recruit immunosuppressive cells to the local environment that keep the microenvironment “cold” and the host immune system at bay. As to the above processes, it appears leronlimab has the ability to disrupt the CCR5 signaling that both promotes the cancer tumor’s growth and protects its microenvironment from the host immune response. By disrupting CCR5 signaling, leronlimab allows the host immune system (CD8+ cells) to identify the cancer cells as a threat and attack them in what has now become a “hot” or inflamed microenvironment (expressing various inflammatory cytokines). To counter the pressure of an attack from the host immune system, the cancer, at least as evidenced on the CTCs, has a secondary line of defense: expressing a protein called PD-L1 and hijacking its relationship to its receptor, PD-1. Ordinarily, PD-1 acts as the immune system’s “off switch”, binding with PD-L1 on functioning immune cells and preventing them from being so strong that they kill healthy cells in the body. Cancer cells capitalize on this system by expressing PD-L1 and binding to the “off switch” on the invading host immune cells, in turn slowing an immune response, thereby protecting the tumor. As observed in patients who were fortunate enough to receive a PD-L1 antibody called an ICI in our prior studies, this “secondary defense” of the tumor can be thwarted. The antibody prevents the PD-L1 protein from binding to the “off switch” (PD-1), keeping the immune system “on” and allowing the host immune system’s attack on the cancer to continue. Typically, patients who have tumors with higher levels of PD-L1 expression derive the most benefit from treatment with an ICI, given there are more opportunities for the antibody to block connections to the “off” switch and allow the immune system to fight the cancer cells. As to this process, preliminary data indicate that leronlimab has the ability to induce higher levels of PD-L1 expression in solid tumor cancer cells. This opens potential new treatment pathways for patients with low PD-L1 levels who would have otherwise been unable to derive benefit from an ICI. The foregoing sequence is a novel working theory; however, our data, first presented at ESMO, suggest that this is what happened in the five patients who are alive today, 48 months after diagnosis. The key findings from our presentation at ESMO included the following: PD-L1 Upregulation: 16/21 (76%) of patients showed a significant increase in PD-L1 expression on CTCs within 30-90 days after starting leronlimab, regardless of dose. This suggests that the tumor microenvironment was turned from “cold” to “hot” (from being protected against host immune invasion to being under host immune attack). Even more remarkably, this shift from “cold” to “hot” occurred in 15/17 (88%) patients who received weekly leronlimab doses of 525 mg or higher. Turning “cold” tumors “hot” means that far more patients with TNBC (and potentially other solid tumors) may become eligible for a class of drugs known as anti-PD-1/anti-PD-L1 treatments and collectively referred to as ICIs.Long Term Survival: The clinical significance of the increase in PD-L1 observed on the CTCs was driven home by the confirmation that 5/5 (100%) of patients who demonstrated a significant increase in PD-L1 expression while receiving leronlimab and received any ICI are alive today, 4+ years later. More remarkably, three of these individuals (60%) are currently identified as having no ongoing evidence of disease. Underscoring the clinical significance of these results is the unfortunate finding that none of the 23 patients who didn’t induce significant PD-L1 expression or didn’t receive an ICI with leronlimab are alive today. Update(s) on Colorectal Cancer and Pending Trial While generating the TNBC dataset, we documented outcomes in patients with other solid tumors previously enrolled in the CD09 “Basket Study.” The results from five such patients with colorectal cancer (“CRC”) were presented at the ESMO GI meeting in Barcelona this past July by the Principal Investigator for our current CRC study, Dr. Ben Weinberg from the Lombardi Comprehensive Cancer Center at Georgetown University. Additional updates on our CRC trial and how we will be using the CRC trial to further establish our working theory on the mechanism of action driving improved survival are included below. The timing of the TNBC observations, data set, and working mechanism of action theory creates a unique opportunity for CytoDyn to evaluate this “cold to hot” paradigm shift in the context of a second solid tumor during our CRC study. Up to 85% of patients with CRC are not currently candidates for ICI therapy because their tumors are “cold” and do not express PD-L1. Our mCRC study design provides leronlimab in both arms of the study. As such, we have amended the protocol to include close monitoring of PD-L1 levels on the CTCs in all enrolled patients. In addition, we are submitting a new rollover protocol to the FDA, which will provide ongoing access to leronlimab for those patients with CRC who continue to do well after 48 weeks on the parent study and will now offer leronlimab plus an ICI to those patients who progress on the parent study. These amendments will allow us to achieve multiple critical goals, including: Evaluate leronlimab as a stand-alone agent (in combination with Standard of Care) in a second solid tumor type;Prospectively evaluate the ability of 2 different leronlimab dose levels to induce PD-L1 expression on CTCs in a solid tumor that is typically “cold” and not usually associated with PD-L1 expression;Obtain biopsy tissue from patients with disease progression enrolling in the rollover protocol to correlate PD-L1 levels and changes in the tumor microenvironment on tumor tissue with PD-L1 expression on concurrently drawn CTCs; andEvaluate the possibility of treating patients with a common and typically “cold” cancer with the combination of leronlimab and an ICI, the same regimen that demonstrated long-lasting remission in 5/5 patients with mTNBC who significantly induced PD-L1, as reported at ESMO. It is fortuitous that we launched the CRC study just as the PD-L1 data came to light, as it allows us to immediately commence efforts to collect certain prospective confirmatory data. Five trial sites have been initiated. It is our hope that the ESMO CRC data, together with the option of receiving leronlimab and an ICI during the rollover protocol, will generate interest among both patients and caregivers and help to expedite enrollment efforts. Investigator-Initiated Study in Glioblastoma In addition to mTNBC and CRC, we are continuing our investigation into a possible role for leronlimab in the treatment of glioblastoma, a third solid tumor type. We have found an individual who has agreed to fund this venture, and we have reached a tentative agreement with two medical centers to support their investigator-initiated pilot study in patients with recurrent glioblastoma. These patients will receive leronlimab in advance of their pending surgery and then start an ICI after surgery. This study is predicated on the prior observation of CNS penetration of leronlimab in macaques, as well as the potentially peripheral site of activity of ICI on T Cells in patients who had their protected tumor microenvironment disrupted while receiving leronlimab prior to surgery. Other Pre-Clinical and Clinical Projects We are pleased to share that the Alzheimer’s study at Cornell University Medical Center in New York has received both FDA and IRB approval, a “kickoff meeting” was just conducted, and enrollment will begin in the coming weeks. As previously noted, this study has been funded by an outside foundation to whom we are very grateful, but that wishes to remain anonymous at this time. Additionally, the LATCH study with Dr. Jonah Sacha and his team at Oregon Health & Science University has been updated and is now ready for IRB and FDA submission. The study will further explore the role of leronlimab in the potential cure of HIV+ patients who receive a stem cell transplant from CCR5+ donors. We were also able to work with Dr. Sacha to arrange for commitments from outside foundation(s) to fund the costs of this study. Pending Publications Our top publication priority remains a comprehensive TNBC manuscript that includes the clinical and PD-L1 data presented at ESMO, as well as recent laboratory data generated by Dr. Richard Pestell that appears to reinforce our belief in leronlimab as a paradigm shift in solid tumor oncology. The initial draft of the manuscript will be ready for internal review in the coming weeks. The Company has also prepared a case report of a patient with mTNBC whose cancer had spread to both brain and lungs, but who is alive today without evidence of disease, almost 5 years after receiving fourth-line treatment with leronlimab plus atezolizumab. That manuscript will be submitted for peer review shortly. The company is also preparing a safety manuscript summarizing the safety data in almost 1,600 patients who have now been treated with leronlimab in CytoDyn-sponsored studies. The company’s manuscript describing the results of CytoDyn’s prior study in patients with Metabolic Dysfunction-Associated Steatohepatitis was recently accepted for publication. Finally, we have recently submitted two additional manuscripts for peer-review, including: A manuscript of a preclinical study of CRC performed at the Cleveland Clinic, which demonstrated a significant reduction in lung metastasis in mice treated with leronlimab.A manuscript summarizing results from SMC Laboratories detailing the effects of leronlimab on liver fibrosis, inflammation, and fat. Note Regarding Forward-Looking Statements This September 2025 Science Supplement contains forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments other than as required by law.

SHANGHAI, Aug. 25, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2025 interim results. In the first half of 2025, Henlius' revenue reached about RMB2.8195 billion, representing an increase of 2.7% YoY. The gross profit of RMB2.1992 billion, up by 10.5% YoY, with a net profit reached RMB390.1 million. Operating cash flow reached RMB770.9 million, with an increase of 206.8% YoY, maintaining a steady positive inflow. Overseas products profits surged over 200%. Cash inflows from BD agreements exceeded RMB 1 billion, surging 280% YoY. As the overseas sales volume of commercialized products continues to rise, the company expects significant growth in overseas revenue and profits for the full year of 2025, with strong momentum likely to continue into 2026. The company remains committed to reinforcing its strategic focus on innovation and globalisation, actively advancing its end-to-end ecosystem to drive sustainable R&D growth with robust growth momentum. During the reporting period, the company invested RMB995.4 million in R&D, with an increase of 21.3% YoY in expensed R&D expenditures, prioritizing preclinical development of differentiated innovative molecules and construction of core innovation platforms. Up to date, Henlius has 6 products launched in China, 4 approved for marketing in overseas markets, benefiting over 850,000 patients and reaching about 60 markets in Asia, Europe, Latin America, North America and Oceania. Meanwhile, the company is expanding its innovation pipeline in disease areas like oncology and autoimmune, advancing a differentiated portfolio of potential best-in-class (BIC) and first-in-class (FIC) candidates. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said "2025 is a pivotal year for Henlius. It is the year we shift into Globalisation 2.0 and step up the pace of innovation. We're strengthening our end-to-end ecosystem and driving overseas revenue growth with global value at scale. Meanwhile, our core innovative products have achieved significant milestones, with the next-generation of high-potential molecules underway. Looking ahead, Henlius will adhere to patient-centricity and accelerate the delivery of superior innovative treatment solutions." Globalisation 2.0: actively advancing the end-to-end ecosystem In the first half of 2025, Henlius' global growth engine was in full swing, with global product revenue exceeding RMB2.5568 billion, representing an increase of 3.1% YoY. Several products are accelerating their expansion into international markets, further improving patient access to essential therapies. The company's core innovative product serplulimab (trade name: HANSIZHUANG in China, Hetronifly® in Europe), the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of small cell lung cancer (SCLC), has recorded a global sales revenue of RMB597.7million during the reporting period. The overseas market expansion of serplulimab has been accelerated in the first half of 2025. It has received approvals in the Europe, Singapore, Malaysia, the United Kingdom and India for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, it has been approved in Indonesia and Thailand for the treatment of squamous non-small cell lung cancer (sqNSCLC). To date, serplulimab has been successfully approved in nearly 40 countries and regions, covering nearly half of the world's population. A head-to-head bridging trial of serplulimab versus first-line standard of care atezolizumab for ES-SCLC in the U.S will also complete patient enrolment soon. The company plans to submit the Biologics License Application (BLA) to the FDA in the first half of 2026. Henlius' core breast cancer product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the "China-developed" mAb biosimilar approved in China, the EU, and the U.S., has recorded a global sales revenue of RMB1.4442 billion in the first half of 2025. During the reporting period, HANQUYOU (trastuzumab) was newly approved in countries including Mexico, bringing its cumulative approvals to over 50 countries and regions worldwide. In the HER2-positive breast cancer segment, Henlius has sequentially combined HANQUYOU (trastuzumab) with HANNAIJIA (neratinib) for extended adjuvant therapy to reduce recurrence risk in early-stage patients. Meanwhile, Henlius' independently developed pertuzumab biosimilar, HLX11, has been accepted for marketing applications by regulatory agencies in China, the U.S., and Europe, and is anticipated to receive approval in th U.S. during the second half of 2025. Focusing on the breast cancer field, Henlius continues to build a comprehensive innovative product portfolio — candidates including Henlius' HLX78 (lasofoxifene), an investigational novel endocrine therapy, the company's novel epitope anti-HER2 mAb HLX22, the next-gen innovative HER2 ADC HLX87, the KAT6A/B inhibitor HLX97 with BIC potential, and the LIV-1 ADC HLX41 are accelerating their research progress. In more disease fields, HLX04-O, a recombinant anti-VEGF humanised mAb injection jointly developed by the company and Essex, for the treatment of wet age-related macular degeneration (wAMD) has been accepted for the New Drug Application (NDA) in China in August 2025. This is the company's first ophthalmic product submitted for marketing approval. The marketing applications for the denosumab biosimilar HLX14, intended for the treatment of osteoporosis and other indications, have been accepted in the U.S., EU, and Canada, with expected approvals in the second half of 2025. In the first half of the 2025, Henlius accelerated the expansion of its core products into major global markets through strategic collaboration, further enhancing the company's international influence and commercial capabilities. The company has entered into agreement with Abbott, granting it exclusive or semi-exclusive licenses for the development and commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets including Asia and Latin America. The company has granted Dr. Reddy's exclusive rights to HLX15, an anti-CD38 mAb, covering a total of 43 countries and regions across the U.S. and Europe. Besides, the company has also entered into an exclusive commercialization and semi-exclusive development collaboration with Lotus for the anti-PD-1 antibody serplulimab in multiple indications in South Korea. Additionally, the company has signed a licensing agreement with Sandoz, granting exclusive commercialization rights for HLX13, an CTLA-4 inhibitor, in the U.S., EU, Japan, Canada, and Australia. In the first half of 2025, leveraging the advanced technologies and extensive resources, the company continued to reinforce its integrated biopharmaceutical platform including R&D, clinical trials, manufacturing, quality management, regulatory affairs, and commercialization. Up to date, the company has submitted over 800 drug registrations, and received more than 600 approvals, covering multiple countries and regions including China, the U.S., the EU, Canada, Indonesia and Japan. It has also conducted MRCTs in the U.S., the EU, Southeast Asia, Japan and other countries and regions, accelerating the globalisation process of its products. During the reporting period, Henlius continues to optimize its production operations and quality management system. The Songjiang Site has once again received the EU GMP Certificate, issued by the Federal Agency for Medicines and Health Products in Belgium, in July 2025. The completion of the Phase 1 of Songjiang Site II in August 2025 has further enhanced the company's production capabilities. Up to now, the company has delivered over 1,150 batches of commercial GMP production, ensuring stable supply to countries and regions including China, Southeast Asia, Europe and Latin America. The company has successfully passed nearly 100 on-site inspections and audits conducted by global regulatory authorities and business partners, and has obtained GMP certifications from China, the EU, the U.S. and multiple PIC/S member countries, including Indonesia and Brazil. Innovation breaks through the growth ceiling In the first half of 2025, the company continued to advance its innovation-driven strategy, accelerating breakthroughs in cutting-edge technology platforms and driving robust growth in its innovative pipeline. Core products such as HLX43, HLX22, and serplulimab have each achieved significant global milestones. HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1 with BIC potential. The results of the phase 1 clinical trial of HLX43 have been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC and thymic squamous cell carcinoma (TSCC). It shows encouraging efficacy in squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative NSCLC patients, indicating its biomarker-independent antitumor potential. Previously, HLX43 has already been approved to conduct phase 2 MRCT in patients with non-small cell lung cancer (NSCLC) in China, the U.S., Japan and Australia, with first patients successfully dosed in both China and the U.S. Simultaneously, as the world's first PD-L1 ADC indicated for thymic carcinoma (TC), HLX43 has received clinical trial approvals for the indication in the U.S. and other regions. A MRCT is planned to be initiated, aiming to fill the therapeutic gap in ADC treatment for this aggressive cancer type. In addition, the company is also accelerating the phase 2 clinical development of HLX43 in various solid tumors, including cervical cancer (CC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC) and gastric/gastroesophageal junction cancer (GC/GEJC). Both monotherapy and combination therapies of HLX43 with other products are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. A phase 3 head-to-head clinical trial of Henlius' novel enpitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy comparing to current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) is steadily progressing. The first patient dosing has been completed in China, the U.S., Japan, Australia, and Korea, regardless of PD-L1 expression, with the aim of overcoming current limitations in first-line treatment of HER2-positive metastatic gastric cancer. Meanwhile, HLX22 has received Orphan Drug Designations from both the U.S Food and Drug Administration (FDA) and the European Commission (EC) in the first half the year for the treatment of gastric cancer, suggesting its significant therapeutic potential. Moreover, the updated data with over two years of follow-up from the phase 2 clinical study (HLX22-GC-201) evaluating HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at the 2025 ASCO Annual Meeting. The study data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up, outperforming previous data and providing solid data foundation for the subsequent phase 3 study. Focusing on lung and gastrointestinal cancer, Henlius is continuously advancing the global clinical development of its self-developed innovative anti-PD-1 mAb serplulimab. In the field of lung cancers, the U.S. and Japanese bridging trial of serplulimab for SCLC, and a phase 3 MRCT of serplulimab combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC) are currently underway in parallel to establish a solid foundation for future overseas regulatory registration, among which the phase 3 MRCT in LS-SCLC has completed the subject enrollment. In the field of gastrointestinal cancers, a phase 3 clinical trial of serplulimab plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the phase 3 MRCT (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) have also completed subject enrollment. During the reporting period, a total of over 20 pivotal studies, investigator-initiated trials (IITs), and real-world studies (RWS) on serplulimab in the fields of lung cancer and gastrointestinal cancer were presented at major international academic conferences such as ASCO GI, ELCC, IGCC, ASCO, and WCLC, and were published in scientific journals including Cancer Immunology, Immunotherapy and Cancer Communications. Among them, the end-of-study analysis of the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC has been first released at the 2025 ASCO Annual Meeting, featuring a four-year OS data of 21.9% and thus validating its long-term survival benefit. While fully leveraging the value of its flagship molecules, the company is actively addressing unmet clinical needs and building an early-stage pipeline of high-potential candidates, creating strong momentum for sustainable, high-quality growth over the medium to long term. During the period, the company continued building and optimizing its competitive R&D platforms, including its ADC platform Hanjugator™ with independent intellectual property, T cell Engager (TCE) platforms, the one-stop drug discovery platform HAI Club, and the independently developed computing platform HAI PBD to enhance R&D capabilities. Meanwhile, building on its core antibody expertise, the company is making ongoing breakthroughs across target coverage and molecular diversity, accelerating multiple candidates toward clinical development, including the potential FIC human sialidase enzyme therapeutic HLX79, HLX701, the novel anti-CD47 SIRPα-Fc fusion protein with good safety profile, anti-PD-L1/VEGF bispecific antibody (BsAb) HLX37, potential BIC KAT6A/B small molecule inhibitor HLX97, TCE platform-derived DLL3xCD3xCD28 TCE HLX3901 and STEAP1xCD3xCD28 TCE HLX3902, Hanjugator™-based EGFRxcMET ADC HLX48, and potential FIC B7H3-sialidase enzyme HLX316. Looking ahead, Henlius will remain committed to its patient-centric mission, accelerate global expansion, drive the efficient implementation of innovation outcomes, and continuously enhance its global product supply as well as quality systems, aiming to bring more high-quality, affordable innovative 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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 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