Recombinant anti-IL-4Rα humanized monoclonal antibody (Sunshine Guojian)

First study comparing blockade of the IL-4 receptor and IL-13 receptor, both components of the Type 2 receptor complex, presented in an oral late-breaking mini-symposium, revealed that IL-13Rα1 blockade with eblasakimab maylead to more potent control of the Th2 inflammatory response and dampening of Th1 proinflammatory cytokines in vitro compared to blockade of IL-4Rα in patients with moderate-to-severe atopic dermatitis Second late-breaker poster presentation highlighted the role of farudodstat, a DHODH inhibitor, in reducing T cell proliferation and potentially preventing loss of immune privilege in an ex vivo translational model of alopecia areata SAN MATEO, Calif. and SINGAPORE, May 15, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Pte Ltd (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the presentation of new eblasakimab and farudodstat data in late-breaker oral and poster presentations respectively, at the 1st International Societies for Investigative Dermatology (ISID) meeting, which took place from May 10 to 13, 2023, in Tokyo, Japan. “This late-breaking data offers new and important insights into the novel mechanisms of eblasakimab and farudodstat for atopic dermatitis (AD) and alopecia areata (AA) respectively," said Dr Ferda Cevikbas, Head of Translational Science at ASLAN Pharmaceuticals. “Data from our collaboration with Dr Shawn Kwatra and Dr Madan Kwatra represent the first evidence of differential downstream effects of blocking the IL-13Rα1 versus the IL-4Rα - two approaches to targeting the Type 2 receptor.” “Selective targeting of the Type 2 receptor by eblasakimab, an antibody targeting the IL-13Rα1, appeared to potently reduce Th2 inflammation while also preventing concomitant Th1 cytokine upregulation,” said Dr Shawn Kwatra, Associate Professor of Dermatology at the Johns Hopkins University School of Medicine. “These data suggest that targeting different subunits of the Type 2 receptor can result in distinct downstream effects and could lead to differential clinical outcomes.” “By sparing the Type 1 receptor and preventing possible unwanted adverse effects of the Th1 immune response, eblasakimab’s selective targeting of the Type 2 receptor offers a promising therapeutic approach in treating AD, compared to targeting the IL-4Rα. We look forward to learning more about the clinical benefits of eblasakimab’s differentiated approach when we announce topline data from our Phase 2 TREK-AD study in early July,” Dr Cevikbas continued. “Furthermore, data from an ex vivo human AA disease model demonstrates the potential for farudodstat to protect against immune privilege collapse in AA. We are grateful to all our experts and research organizations who partnered with us for these studies.” 2023 ISID late-breaker poster details: Eblasakimab Oral presentation in mini symposium on May 13 and ePoster presentation Downstream effects of IL-13α1 blockade on Type 2 inflammation and Th1 immune axis activation in atopic dermatitis (abstract ID: LB1751) Current evidence indicates that the pathogenesis of AD involves two critical cytokines, IL-4 and IL-13, which mediate type 2 helper T cell (Th2)-driven inflammation through the Type 1 receptor (composed of IL-4Rα and the common gamma chain) and Type 2 receptor (composed of IL-4Rα and IL-13Rα1)1. The contributions of Type 1 and Type 2 signalling in driving Th2 inflammation are currently unknown and hence we have yet to understand the most effective way to inhibit Th2 inflammation in patients with AD. This study evaluates the effect of blocking either 1) both Type 1 and Type 2 receptors signalling, using anti-IL-4Rα antibody, or 2) only Type 2 receptor signalling using eblasakimab, a monoclonal antibody that binds IL-13Rα1. The protocol used isolated peripheral blood mononuclear cells (PBMCs) from patients with moderate-to-severe AD to examine the downstream effect of anti-IL-4Rα antibody or eblasakimab on Th2-inflammatory and Th1-immune related cytokines. IL-13Rα1 blockade with eblasakimab was associated with statistically significant lower levels of Th2-key cytokines including TARC, IL-13, IL-4 and MCP-4 compared to blockade of IL-4Rα. Furthermore, the activation of Th1 cytokines, including TNF-α, IL-2, GM-CSF, IL-12 and IP-10, was significantly increased with anti-IL-4Rα treatment as compared to eblasakimab treatment. Collectively, the data indicates that selective targeting of the IL-13Rα1 with eblasakimab may lead to a more potent control of Th2 inflammatory response while dampening Th1 activation compared to targeting IL-4Rα. Farudodstat A novel ex vivo model of human hair follicle immune privilege collapse reveals the potential of farudodstat, a DHODH inhibitor, as a therapeutic for alopecia areata treatment (abstract ID: LB1777) Alopecia areata (AA) is an autoimmune disease characterized by inflammation in hair follicles (HF), loss of immune privilege (IP) and a Th1 mediated-inflammatory response leading to hair loss2. Dihydroorotate dehydrogenase (DHODH) plays a key role in T-cell proliferation and its inhibition decreases Th1-cell differentiation and IFNγ production3,4, but its role in AA pathophysiology is yet to be fully understood. This study investigated whether farudodstat, a DHODH inhibitor, has potential in the treatment of AA using an innovative ex vivo model for AA. Our novel ex vivo model used microdissected HFs from healthy human donors stimulated with anti-CD3/CD28 antibodies to promote intra- and peri-follicular T-cell activation. When anti-CD3/CD28 was applied to healthy HFs there was 1) an increase in CD3+ and CD3+ Ki-67+ in the epithelium and mesenchyme, indicative of T cell activation and proliferation 2) increased expression of key markers MHC I and II proteins which revealed loss of IP. Subsequent treatment with farudodstat significantly reduced the proliferation of T-cells, decreased MHC expression and the number of MHC-II+ cells in the hair bulb, suggesting potential protection from IP loss. Farudodstat alone did not affect hair matrix keratinocyte proliferation or IP markers, suggesting no signs of cytotoxicity were observed in healthy HFs. Together, the findings highlight the potential for farudodstat as a novel therapy for AA. The posters presented at the conference are available in the Publications section of ASLAN’s website. References 1 Junttila IS (2018) Front Immunol 9:888 2 Bertolini et al (2020) Exp Dermatol 29:1-23 3 Steinert et al (2021) Annu Rev Immunol 39:395-416 4 Klotz et al (2019) Sci Transl Med 1:11(490) About eblasakimab Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor subunit of the Type 2 receptor, a key pathway driving several allergic inflammatory diseases. Eblasakimab’s unique mechanism of action enables specific blockade of the Type 2 receptor and has the potential to improve upon current biologics used to treat allergic disease. By blocking the Type 2 receptor, eblasakimab prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13) – the key drivers of inflammation in atopic dermatitis (AD). Positive results from a Phase 1b multiple-ascending-dose study established proof-of-concept for eblasakimab and supported its potential as a novel, differentiated treatment for AD. ASLAN is currently conducting TREK-AD, a Phase 2b trial to evaluate eblasakimab in biologic naïve moderate-to-severe AD patients, with topline readout expected in early July 2023. ASLAN is also investigating eblasakimab in dupilumab experienced, moderate-to-severe AD patients in the Phase 2 trial TREK-DX, with data expected in the first quarter of 2024. About farudodstat Farudodstat is a potent, oral DHODH inhibitor that suppresses immune cell proliferation and IFN-γ secretion by blocking de novo production of pyrimidines required for DNA replication. Compared to first-generation DHODH inhibitors, farudodstat has been shown to be approximately 30 times more potent in its inhibition of DHODH and limiting T cell activity and has demonstrated a well-tolerated safety profile. ASLAN has generated data showing that farudodstat can protect against the loss of immune privilege in hair follicles, supporting its potential as a first-in-class treatment option for alopecia areata (AA). About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease. Eblasakimab is being investigated in a global Phase 2b trial of moderate-to-severe AD patients with topline readout expected in early July 2023. ASLAN is also developing farudodstat, a potent oral inhibitor of the enzyme DHODH, as a potential first-in-class treatment for alopecia areata (AA) and plans to initiate a proof-of-concept trial in 2Q 2023. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the website or follow ASLAN on LinkedIn. Forward-looking statements This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for eblasakimab and farudodstat; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a first-in-class treatment for alopecia areata; and the Company’s cash runway. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia and bank failures on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Media and IR contacts Emma Thompson Spurwing Communications Tel: +65 6206 7350 Email: ASLAN@spurwingcomms.com Ashley R. Robinson LifeSci Advisors, LLC Tel: +1 (617) 430-7577 Email: arr@lifesciadvisors.com

HONG KONG, March 21, 2023 /PRNewswire/ -- Chinese leading biopharmaceutical company 3SBio (01530.HK) today announced its 2022 annual results. In 2022, 3SBio's core biopharmaceutical products posted robust growth, hair health business achieved blistering performance, and contract development and manufacturing organization (CDMO) business demonstrated big potential. New drugs started to embrace a commercialization wave, and license-out and license-in partnerships geared up. Revenue in 2022 increased by 7.5% year on year to approximately RMB 6.90billion. Gross profit rose 7.5% year on year to approximately RMB 5.67 billion. The normalized earnings before interest, taxes, depreciation and amortization (EBITDA) were approximately RMB2.80 billion, an increase of 27.7% over the same period last year. The normalized net profit attributable to owners of the parents was approximately RMB2.16 billion, a rise of 25.2% over the same period last year. The solid performance growth supported a sustainable dividend policy. According to the resolution of the board of directors, 3SBio will pay a dividend of HKD0.1. This year marked the 30th anniversary of 3SBio. On top of steady financial performance growth, the Company has been delivering on its corporate social responsibility and constantly improving environmental, social and governance (ESG) management. In 2022, 3SBio improved from A to AA on the MSCI ESG rating, surpassing 88% of the world's biotechnology companies. In the future, 3SBio will further expand its advantages as an integrated platform for research and development (R&D), manufacturing, commercialization and external partnerships, and consolidate and enhance its status as a leading biopharmaceutical company. Core biopharmaceutical products posted robust performance In 2022, the Company's core products (TPIAO, Yisaipu, EPIAO/SEPO, Mandi) maintained their leadership in the Chinese market, and Cipterbin saw a significant rise in its sales. According to IQVIA data, sales of TPIAO, the world's only commercial recombinant human thrombopoietin (rhTPO) used to treat thrombocytopenia, totaled RMB 3.40 billion in 2022, a year-on-year increase of 10.3%. In 2022, TPIAO achieved a renewal in the National Reimbursement Drug List (NRDL) and it was listed with the highest-level recommendation by the Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines for the Diagnosis and Treatment of Cancer Therapy Induced Thrombocytopenia (CTIT) (2022 Edition). As the leaders in the recombinant human erythropoietin (rhEPO) market for 20 years, EPIAO and SEPO maintained their leading position, with sales of RMB 1.13 billion in 2022, maintaining a dominant market share of 44.5%. Sales of Yisaipu for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis were RMB 512 million. Its safety and efficacy have been verified in the Chinese market for 18 years. Compared with developed countries in Europe and the United States, the penetration rate of biologic anti-rheumatic drugs in China's mainland is still low, and the product has broad growth potential in the future. Sales of Cipterbin for the treatment of HER2-positive metastatic breast cancer were RMB 159 million, an increase of 138.1% year on year, and the number of hospitals and patients covered had a significant rise compared with 2021. In 2022, Cipterbin was successfully renewed in the NRDL and the reimbursement restrictions for its use in combination with vinorelbine were abolished. The CSCO Clinical Guidelines for the Diagnosis and Treatment of Breast Cancer (2022 Edition) listed Cipterbin with the highest-level Class I recommendation for the treatment of patients with HER2-positive advanced breast cancer. Hair health business achieved blistering growth The Company's hair health business achieved blistering growth. Sales of the key product Mandi (minoxidil tincture) were RMB 891 million in 2022, representing a year-on-year increase of 48.1%. Sales through retail pharmacies soared 65% year on year, and sales through e-commerce channels jumped 58% year on year, maintaining strong growth momentum and driving up the penetration rate of the Mandi brand. As an effective hair growth therapy, Mandi (5% minoxidil) has been granted the highest-level recommendation in the Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia in Chinese Population and the Chinese Expert Consensus on the Diagnosis and Treatment of Androgenetic Alopecia in Women (2022 Edition). 3SBio is committed to enhancing customer education regarding the use of Mandi for individuals experiencing hair loss, as well as improving the application cycles of the drug in the treatment of hair loss. In the future, the educational campaign will help improve the penetration rate of this product and thus further expand its market share. CDMO business demonstrated big potential The Company's CDMO business made significant progress. In 2022, 3SBio completed a total of RMB 166 million worth of CDMO customer orders, marking a year-on-year increase of 49.6%, which demonstrated remarkable results in the first year of operation. The CDMO business has secured customer orders valued at more than RMB 100 million, including partnerships with leading Chinese and overseas pharmaceutical companies and biotech companies, and its services cover all aspects ranging from pre-clinical to commercialization. 3SBio's CDMO business has multiple competitive advantages, including the technological advantages associated with engaging in the whole process spanning from R&D to production of biopharmaceutical products over the years; the scalable cost advantages of a single 10,000-litre bioreactor for commercial production; the production cost advantages brought by the capability to manufacture raw materials such as culture medium and chromatography filling . 3SBio will focus on providing proprietary and cost-effective biological CDMO services, in a bid to help customers accelerate the launch of high-quality new drugs, and expand its own CDMO business. New drugs embraced a commercialization boom under robust pipelines In 2022, 3SBio posted a total R&D cost of approximately RMB 693 million. There were 31 product candidates within the active pipeline, with 26 being developed as innovative drugs. Among them, there were 7 product candidates in oncology, 13 product candidates that target auto-immune and other diseases, 9 product candidates in nephrology; and 2 product candidates in dermatology. Among them, the pipeline in the field of auto-immune diseases, which includes anti-IL-4Rα antibody, anti-IL-5 antibody, anti-IL-1β antibody and anti-IL-17A antibody, was among the leading pack in clinical research progress in China. The Company's pipeline includes a number of upcoming blockbuster products. Among them, the new drug applications (NDAs) on new formulations or indications of three core products have been accepted. The anti-TNF α pre-filled aqueous injection solution of Yisaipu (301S) will address limitations of the powder injection, and will significantly improve the treatment compliance among hundreds of thousands of medical professionals and patients. Minoxidil foam(MN709) is the only one of its kind domestically, adding a medication choice for hair loss patients with sensitive scalp. The phase III clinical trial of TPIAO for pediatric immune thrombocytopenia (ITP) met the preset primary endpoint, and it is expected to meet the treatment needs of children with ITP. In addition, the candidates acquired via external partnerships also achieved big progress. The NDA application of nalfurafine hydrochloride (TRK820) for the treatment of refractory pruritus in patients undergoing maintenance hemodialysis has been accepted, which is expected to fill the treatment gap for dialysis pruritus in China and bring significant clinical benefits to millions of patients with nephrology and liver diseases. 3SBio will continue to focus on four fields of its strength, namely, nephrology, autoimmune diseases, hair and skin, and oncology, and accelerate the candidates that lead in R&D progress in China. The Company will fast-track the auto-immune products with R&D progress surpassing domestic peers;and supercharge the bridging clinical trials for Clascoterone cream in acne indication and Remitch in liver diseases pruritus, both with vast market potentials and targeting an extraordinary number of patients.. Eight new products are expected to be launched in 2023, and the Company will submit NDAs for more than 10 products in the next three years, ushering in a boom in new drug launches. License-out and license-in partnerships geared up In 2022, 3SBio continued to accelerate external partnerships by licensing in high-quality products and licensing out its own products. For example, the Company entered into a licensing agreement with Syncromune Inc, a bio-pharmaceutical company headquartered in the U.S., to develop and commercialize the Company's anti-programmed cell death protein 1 (PD1) mAb (609A) for use with Syncrovax™ immuno-oncology combination therapy worldwide. The Company signed a licensing cooperation agreement with Chengdu Kelingyuan Pharmaceutical Technology Co Ltd to grant the worldwide development and commercialization rights of Cipterbin antibody sequence for antibody-drug conjugate (ADC) to Kelingyuan. The Company also entered into a cooperation agreement with Cosmo Pharmaceuticals N.V. to obtain exclusive right to develop and commercialize Winlevi®, the world's first marketed topical androgen receptor inhibitor to treat acne under its subsidiary Cassiopea, in Greater China. In the future, 3SBio will continue to selectively seek M&A and cooperation opportunities to enrich its portfolio and prepare for future growth. Dr. Jing LOU, Chairman and CEO of 3SBio, commented: "Since its establishment 30 years ago, 3SBio has consistently improved its financial performance and advanced new drug research and development. This has led to robust momentum in its four business segments, empowering the Company's sustainable development. Moving forward, 3SBio is committed to sharpening its focus on refined management and ensuring the healthy development of all business lines. The company will continue to dedicate significant efforts towards the delivery of new drug discoveries. Furthermore, 3SBio is fully committed to its social responsibilities, and is determined to benefit more patients with its high-quality and high-standard drugs." About 3SBio Inc. 3SBio is a leading bio-pharmaceutical company integrating research and development (R&D), manufacturing and commercialization, with a focus on improving the life quality of patients with high-quality medicines to benefit human health. At present, the Company owns more than 100 national invention patents and has launched more than 30 products into the market, covering several therapeutic areas such as nephrology, oncology, autoimmune diseases, ophthalmology and dermatology. The Company owns four R&D centers of the National Engineering Research Center of Antibody Medicine and dual platforms for biopharmaceutical and chemical medicine. The Company has a pipeline of 31 products under R&D, and 26 of them are the national new drugs. The Group also owns five production bases complying with the GMP standards. In the future, 3SBio will continue to uphold the concept of "Care for Life, Cherish Life, Create Life" to foster a world-leading biopharmaceutical company in China. Please visit for additional information. Cautionary Note and Forward-Looking Statements This press release contains forward-looking statements, such as those relating to business or products outlook, or Company's intent, plans, beliefs, expectation and strategies. These forward-looking statements are based on information currently available to the Company and are stated herein on the basis of the outlook at the time of this press release. They are based on certain expectations, assumptions and premises, some of which are subjective or beyond our control. These forward-looking statements may prove to be incorrect or may not be realized in the future. With respect to any new product or new indication, we cannot guarantee that we will be able to successfully develop or eventually launch and market such product or indication. Underlying the forward-looking statements is a large number of risks and uncertainties. Further information regarding such risks and uncertainties may be found in our other public disclosure documents. The scientific information involved may only be preliminary and empirical. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company. View original content to download multimedia: SOURCE 3SBio Company Codes: HongKong:1530