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Pictured: Novartis' office in Marburg, Germany/iStock, TBE Novartis is discontinuing the development of the anti-TGFβ antibody NIS793 and is returning it to Xoma Corporation, according to an SEC filing posted Friday. Following the discontinuation, Novartis will stop enrollment into all active clinical studies of NIS793 but will still collect data once these studies have concluded. After returning to Xoma, NIS793 will also remain an investigational compound. “Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available,” Xoma wrote in its SEC filing. NIS793 is a fully human and potentially first-in-class monoclonal antibody that works by blocking the TGFβ cytokine, a protein involved in many cancer pathways including metastasis, vascular remodeling and immune evasion. The candidate had previously won the FDA’s Orphan Drug Designation for pancreatic cancer in July 2021. Novartis first gained access to NIS793 in October 2015, when it bought the asset from Xoma for $37 million upfront. The deal also involved up to $480 million in regulatory and commercial milestones. Before ending its development, Novartis was running a Phase III trial for NIS793 in pancreatic ductal adenocarcinoma, testing the candidate in combination with gemcitabine and nab-paclitaxel in the first-line setting. Novartis signed another licensing deal with Xoma in August 2017, gaining worldwide commercial rights to its anti-IL-1β antibody gevokizumab for $31 million. Prior to the deal, the candidate had already failed a Phase III trial for Behcet’s disease uveitis. Novartis is currently developing gevokizumab for the first-line treatment of colorectal cancer, with earlier planned submissions starting in 2026. The pancreatic cancer space has seen major developments lately. Last week, Exelixis stopped and unblinded its Phase III CABINET trial in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NET) following “dramatic improvement” associated with its Cabometyx. There is currently no standard of care for NET patients who progress after initial treatment, representing a large unmet medical need. Cabometyx could potentially present these patients with a strong and effective treatment option. Exelixis will engage regulatory authorities using data from CABINET. In June 2023, Ipsen announced that the FDA had accepted its supplemental New Drug Application, seeking to expand Onivyde (irinotecan liposome injection) into the first-line setting for metastatic pancreatic ductal adenocarcinoma. Its application included data from the Phase III NAPOLI trial, which demonstrated significantly better overall and progression-free survival associated with Onivyde versus nab-paclitaxel and gemcitabine. The FDA’s verdict is due early next year. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.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