Latest news with #ThyroidEyeDisease
National Post
6 days ago
- Business
- National Post
Biocytogen and Nanjing Chia Tai Tianqing Announce IND Approval in China for Co-Developed Anti-IGF-1R Antibody NTB003 (BCG009)
Article content BEIJING & NANJING, China — Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ('Biocytogen', HKEX: 02315) and Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. ('NJCTTQ') announced that NTB003 (formerly BCG009), a co-developed injectable drug candidate, has received the Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). The approved indication is Thyroid Eye Disease (TED). Article content About NTB003 Injection Article content NTB003 is a second-generation fully human anti-IGF-1R monoclonal antibody co-developed by Biocytogen and Nanjing Chia Tai Tianqing. Antibody discovery and optimization were completed by Biocytogen using its proprietary RenMab™ fully human antibody discovery platform, while Nanjing Chia Tai Tianqing was responsible for CMC process development, GLP-compliant toxicology studies, and IND application. Compared with first-generation approved anti-IGF-1R therapeutics, NTB003 demonstrates enhanced molecular affinity, improved druggability, and an extended half-life. In vitro studies have shown that NTB003 exerts potent signal-blocking activity and effectively inhibits the release of hyaluronic acid (HA), indicating strong potential for further clinical development. Article content Clinical studies of teprotumumab and other investigational anti-IGF-1R biologics have demonstrated that targeting IGF-1R can deliver significant clinical benefits. These agents have shown rapid onset of therapeutic response and favorable outcomes in reducing proptosis and diplopia, improving quality of life, and lowering clinical activity scores in patients with TED. Article content Nanjing Chia Tai Tianqing will lead the clinical development and commercialization of NTB003 in China, aiming to provide an improved therapeutic option for Chinese TED patients. Biocytogen will be responsible for the global out-licensing of the product outside China. Article content About Biocytogen Article content Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice ® (RenMab ™ / RenLite ® / RenNano ® / RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice ® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit Article content Article content Article content Article content Article content Contacts Article content Biocytogen Contacts Article content Article content Article content
Business Wire
07-05-2025
- Business
- Business Wire
Amgen's TEPEZZA ® ▼ (teprotumumab) Granted Marketing Authorisation as the First Targeted Treatment Specifically for Adults With Moderate-to-severe Thyroid Eye Disease (TED) in the United Kingdom
CAMBRIDGE, England--(BUSINESS WIRE)--Today, Amgen announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for TEPEZZA ® (teprotumumab) as the first therapy specifically licensed for the treatment of adult patients with moderate-to-severe Thyroid Eye Disease (TED). Affecting approximately 50,000 people in the UK, 1 TED is a progressive and potentially vision-threatening condition, which can cause eye bulging, double vision, eye pain, redness and swelling. 2 People living with TED often experience anxiety and depression, concerns about their facial appearance and a loss of confidence. 3 This can impact their ability to work, socialise and maintain relationships. 3,6 'The marketing authorisation for teprotumumab as the first therapy specifically licensed for Thyroid Eye Disease (TED) in the UK marks a step forward for the patient community,' said Dr Tony Patrikios, Executive Medical Director, Amgen UK & Ireland. 'TED can negatively affect patients' lives impacting vision, causing eye pain, making everyday tasks difficult and causing a loss of self-confidence. This authorisation introduces a new alternative treatment option and reinforces Amgen's commitment to supporting eligible patients with serious, underserved conditions.' Teprotumumab's marketing authorisation in the UK is supported by multiple clinical studies, 5,7,8,9 including the Phase 3 clinical trial, OPTIC (n=83). 5 Other clinical studies that supported the marketing authorisation in the UK include the TED01RV Phase 2 clinical study (n=88), 7 the HZNP-TEP-403 Phase 4 clinical study (n=62), 8 and the OPTIC-J Phase 3 study in Japan (n=54). 9 In the OPTIC trial, teprotumumab demonstrated a statistically significant improvement in the primary endpoint, proptosis (eye bulging) responder rate at 24 weeks, with 83% (34/41) of patients demonstrating a reduction of at least 2mm compared to baseline, versus 10% (4/42) of patients treated with placebo (difference of 73%, 95% confidence interval, 59 to 88; P=<0.001]). 5 'For adult patients living with Thyroid Eye Disease (TED), it can be challenging to receive a diagnosis and referral to specialist centres. TED is often mistaken for other more common conditions, which can be frustrating and distressing for patients. This may also lead to delays in receiving treatment. When patients are diagnosed with TED, they are currently faced with limited treatment options targeting 'generalised inflammation'. These treatments do not specifically target the underlying cause and drivers of TED,' said Dr Jimmy Uddin, Consultant Ophthalmologist, Oculoplastic & Orbital Surgeon, Moorfields Eye Hospital and St George's Hospital Medical School. 'Teprotumumab offers eligible TED patients in the UK an important new treatment option.' The safety data for teprotumumab is based on multiple clinical studies. 5,7,8,9 The most common side effects observed in clinical trials are muscle spasms (27.6%), diarrhoea (14.5%), hearing impairment (13.8%), alopecia (13.2%), hyperglycaemia (13.2%), fatigue (12.5%), nausea (10.5%), headache (10.5%), dry skin (9.9%), dysgeusia (8.6%), COVID-19 (6.6%), ear discomfort (6.6%) and nail disorder (5.9%). 4 Amgen will work with the National Institute for Health and Care Excellence (NICE) to seek reimbursement of teprotumumab for all eligible patients. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Notes to Editors About Thyroid Eye Disease (TED) TED is a serious, progressive and potentially vision-threatening autoimmune disease. 10 It often occurs in people living with Graves' disease, but is a distinct disease that is caused by autoantibodies activating an insulin-like growth factor-1 receptor (IGF-1R)-mediated signalling complex on cells within the retro-orbital space. 11,12 This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness. 13,14 Early signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and double vision. 2 About teprotumumab Teprotumumab is a monoclonal antibody that specifically targets and blocks the insulin-like growth factor-1 receptor (IGF-1R), which is thought to play a central role in the development of TED. 15 It binds to the IGF-1R, preventing it from being activated and sending signals that lead to muscle and tissue expansion, as well as inflammation behind the eye. 15 This can help reduce TED symptoms, such as proptosis (eye bulging). 4,5 For further product information, please see the Summary of Product Characteristics, which will be available at: About the Phase 3 OPTIC clinical trial A prospective, multi-centre randomised, double-blind, placebo-controlled, Phase 3 trial of the IGF-1R inhibitor teprotumumab or placebo in adults with Graves' disease and active moderate-to-severe thyroid eye disease. 5 83 patients between the ages of 18-80 were recruited and randomised 1:1 to receive 8 intravenous infusions of either teprotumumab or placebo. Infusions were administered every 3 weeks over 21 weeks, with a final clinical evaluation at week 24. The initial dose of teprotumumab was 10mg/kg, with each subsequent infusion dosed at 20mg/kg. 5 The primary endpoint of the trial was proptosis response, defined as a reduction of at least 2mm in proptosis from baseline in the study eye without a corresponding increase of at least 2mm in the fellow (contra-lateral) eye at week 24. 5 For more information on the OPTIC clinical trial go to: About Amgen UK Amgen's mission is to serve patients. A biotechnology innovator since 1980, our science- based heritage is at the heart of everything we do. We remain on the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. In the UK, Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. As a regional hub, we employ around 650 people in the UK and Ireland across our commercial, R&D and corporate functions. Committed to driving sustainable solutions that can adapt to an ever-evolving health system, we are proud to serve patients every day. For more information visit: References 1 British Thyroid Foundation. Thyroid eye disease. Available at: Last accessed: May 2025. 2 Royal National Institute of the Blind (RNIB). Thyroid eye disease. Available at: Last accessed: May 2025. 3 Smith TJ, et al. How patients experience thyroid eye disease. Front. Endocrinol. 2023;9(14):1283374. 4 TEPEZZA (teprotumumab) Summary of Product Characteristics. Will be available at: 5 Douglas RS, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med 2020;382:341-352. 6 British Thyroid Foundation. Thyroid eye disease: patient leaflet. Available at: Last accessed: May 2025. 7 Smith TJ, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med 2017;376:1748-1761. 8 Douglas RS, et al. Efficacy and Safety of Teprotumumab in Patients with Thyroid Eye Disease of Long Duration and Low Disease Activity. JCEM 2024;109(1):25-235. 9 Hiromatsu Y, et al. A randomised, double-masked, placebo-controlled trial evaluating the efficacy and safety of teprotumumab for active thyroid eye disease in Japanese patients. Lancet Reg Health West Pac. 2025;55:101464. 10 Ponto KA, et al. Quality of life and occupational disability in endocrine orbitopathy. Dtsch Arztebl Int. 2009;106(17):283-289. 11 Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257. 12 Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves' Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354. 13 McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves' Orbitopathy (EUGOGO ) survey. Br J Ophthalmol. 2007;91:455-458. 14 Bartalena L, et al. The 2021 European Group on Graves' Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves' Orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. 15 Patel A, et al. A New Era in the Treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288.
NDTV
06-05-2025
- Health
- NDTV
Bulging Eye Disease Cases Rising Among Women Over 40: Report
Thyroid Eye Disease (TED) is increasingly affecting women over 40, causing bulging eyes due to inflammation and swelling around the eyes. This autoimmune condition often occurs in people with hyperthyroidism (overactive thyroid) or Graves' disease. Common symptoms include: Dry or Gritty Eyes: Irritation and Discomfort Sensitivity to Light: Increased sensitivity Ache Behind the Eyes: Pain that worsens when looking up Bulging Eyes: Eyes protruding from the socket Effects of Proptosis (Bulging Eyes) on Your Well-Being According to the Cleveland Clinic, the condition can affect your appearance, leaving you with a startled expression that doesn't go away. Proptosis (Bulging Eyes) can also make it difficult for you to blink. When you can't blink, the protective outer layer of your eyes (corneas) doesn't receive the lubrication it needs to do its job. You may be at risk for cornea damage. Some people experience other complications, like low vision or double vision (diplopia). Other names for proptosis include bulging eyes, protruding eyes and exophthalmos. TED affects approximately 50,000 people in the UK, with women being five times more likely to develop the condition than men. If left untreated, TED can lead to sight loss and have a devastating impact on mental health. Treatment options include steroids, lubricating eye drops, and surgery. Researchers are exploring new treatments, such as targeted drugs acting on the immune system. Early diagnosis and treatment are crucial to managing symptoms and preventing long-term damage.
Yahoo
17-03-2025
- Business
- Yahoo
HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease
Batoclimab receives Orphan Drug Designation in Japan, advancing treatment for active Thyroid Eye Disease (TED). Batoclimab, subcutaneous formulation, offers the potential for at-home administration, improving patient convenience and accessibility. Phase 3 study to confirm the potential of batoclimab to address unmet needs of patients with TED in process, with top-line results expected in the 2H 2025. SEOUL, South Korea, March 17, 2025 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, announced that Batoclimab, an anti-FcRn treatment being developed for a range of autoimmune diseases, has received Orphan Drug Designation (ODD) from the Ministry of Health, Labor and Welfare (MHLW) in Japan for active Thyroid Eye Disease (TED). The Orphan Drug Designation (ODD), granted by the MHLW, is awarded to drugs and biologics intended to treat rare diseases affecting fewer than 50,000 people in Japan, with eligibility based on criteria such as patient population size, medical needs, and the feasibility of development, and possibility of development[1]. Currently, it is estimated that approximately 35,000 people in Japan are affected by TED.[2] "We are thrilled to have received Orphan Drug Designation for Batoclimab in Japan, marking an important milestone in our efforts to bring this promising treatment to patients in need," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "This designation highlights the potential impact Batoclimab could have on the lives of patients with TED. We remain dedicated to advancing the development of this treatment and are focused on bringing it closer to the market." Batoclimab is a monoclonal antibody designed to target and inhibit FcRn, which plays a crucial role in recycling IgG antibodies. By selectively binding to FcRn, Batoclimab reduces the levels of harmful IgG antibodies, offering the potential to treat a variety of IgG-mediated autoimmune diseases. Being developed as a subcutaneous (SC) formulation, Batoclimab is expected to allow patients to administer the treatment at home, improving convenience and accessibility. Currently, Batoclimab is being investigated globally for conditions such as generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease. HanAll, with its licensee, is conducting a Phase 3 study of Batoclimab in active TED. The study, which includes patient enrollment in Japan, aims to confirm the efficacy and safety of Batoclimab as a potential new treatment for individuals affected by TED. Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is a rare and debilitating autoimmune disorder primarily affecting individuals with hyperthyroidism or Graves' disease. TED is characterized by a range of severe symptoms, including eye bulging, pain, double vision, and, in some cases, vision loss. TED can severely limit daily activities such as reading, driving, and working. In addition, many individuals face significant social and psychological challenges, including concerns about their appearance, anxiety, low mood, and social withdrawal. Currently, treatment options for those with moderate to severe cases of TED remain limited, highlighting the urgent need for more effective therapies to improve patient outcomes and quality of life. About HanAll Biopharma HanAll Biopharma (KRX: is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is being evaluated in Graves' Disease (GD) and Rheumatoid arthritis (RA). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 VELOS-4 study in the US and is also being evaluated in China for the treatment of dry eye disease. Results from the Phase 1 study, HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease (PD), have been released, and the preparations to initiate a next study in patients with PD is progressing. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@ ir@ Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2025 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. [1] Regulation by MHLW: [2] Natsuko W et al. J Endocr Soc. 2023 Nov 27;8(1):bvad148. View original content to download multimedia: SOURCE HanAll Biopharma Sign in to access your portfolio
