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RemeGen Demonstrates Profitability to Successfully Receive Approval from the Hong Kong Stock Exchange to Upgrade Stock Short Name

RemeGen Demonstrates Profitability to Successfully Receive Approval from the Hong Kong Stock Exchange to Upgrade Stock Short Name

The "B" marker is removed from the Company's stock short name

YANTAI, China, June 5, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a fully-integrated commercial-stage biotechnology company, successfully obtained approval from The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") on June 5, 2023 to remove the "B" marker from its stock short name as the Company's financial performance in 2022 met the market capitalization/revenue test under Rule 8.05(3) of the Hong Kong Stock Exchange's Listing Rules. This marks another significant milestone in RemeGen's development as it is transforming itself from a research-oriented biotech company to a fully-integrated biopharmaceutical company.

Mr. Wang Weidong, RemeGen's chairman and executive director, said, "Despite facing a number of macro and industry headwinds in 2022, we nonetheless pushed ahead to make significant achievements that have led us to this approval from the Hong Kong Stock Exchange. Looking ahead, we expect momentum to continue both in China and around the globe in 2023 and beyond. We are well-positioned to accelerate growth and deliver strong shareholder returns while developing first-in-class and best-in-class products to help patients with unmet medical needs."

For the year ended December 31, 2022, RemeGen had a realized revenue of approximately RMB768 million and a gross profit of approximately RMB498 million. During the reporting period, product sales revenue hit approximately RMB738 million, marking a massive year-on-year increase of 462.2%. The sales revenue from telitacicept (RC18) and disitamab vedotin (RC48) saw fast growth in 2022 as the two drugs were included in the National Medical Insurance Drug List (NRDL) in China at the end of 2021 and smooth progress of commercialization. Leveraging its strong research and development platform, RemeGen has discovered and developed a robust product pipeline with more than ten drug candidates. Among these, seven are in the clinical development stage targeting over 20 indications. Two of the commercialization stage drugs, telitacicept and disitamab vedotin, are in clinical trials targeting 18 indications in China and the United States.

RemeGen's impressive business progress for the past year includes:

- Telitacicept (RC 18): Telitacicept is currently being evaluated in late-stage clinical trials for several autoimmune diseases that aim to address the large number of unmet or underserved areas in this therapeutic area to include, systemic lupus erythematosus (SLE), lupus nephritis (LN), immunoglobulin A nephropathy (IgAN), primary Sjogren's syndrome (pSS), rheumatoid arthritis (RA), myasthenia gravis (MG), neuromyelitis optica spectrum disorder (NMOSD), as well as multiple sclerosis (MS).

- Disitamab vedotin (RC 48): RemeGen is developing disitamab vedotin for a variety of HER2-expressing cancer types and strategically focuses on clinical studies for the treatment of gastric cancer (GC), urothelial cancer (UC) and breast cancer (BC) in China, which suggest particularly significant unmet medical needs. The Company is also exploring the efficacy of disitamab vedotin on other prevalent cancer types expressing HER2 including non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), gynecological malignancies, advanced melanoma, among others. In January 2023, RemeGen's disitamab vedotin for the treatment of patients with HER2-expressing locally advanced or metastatic UC was successfully included in the new version of the NRDL, with the new price came into effect on March 1, 2023.

- RC28: RC28 is a novel fusion protein targeting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). RemeGen is evaluating and planning to evaluate the efficacy of RC28 in several ophthalmic diseases in clinical studies, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). In Phase I clinical trial, no safety concerns were detected for up to 2.0 mg injection of RC28 in wAMD patients.

- Other clinical-stage drug candidates from RemeGen include RC88, RC98, RC108, and RC118.

Commercialization of Product Portfolio

From a commercialization perspective, RemeGen has established a sales and marketing department fully dedicated to the commercialization of pipeline products. According to the indications of the Company's products, two independent sales teams have been built in the fields of autoimmunity diseases and oncology, respectively.

As the world's first innovative dual-target biologics for the treatment of SLE, telitacicept was approved for marketing and telitacicept for the treatment of SLE was included in the updated NRDL in 2021. In 2022, the team covered 1,876 hospitals across the country and as of December 31, 2022, the commercialization team for autoimmune diseases successfully launched the drug in 495 hospitals and 1,015 direct-to-patient (DTP) pharmacies.

Disitamab vedotin for the treatment of HER2-expressing locally advanced or metastatic gastric cancer (GC) was included in the updated NRDL in December 2021. In 2022, the commercialization has covered 1,419 hospitals in China. As of end of 2022, the commercialization team for autoimmune diseases had been admitted to 472 hospitals.

Looking ahead to 2023 and beyond

In China, RemeGen will continue to be committed to the commercialization of telitacicept and disitamab vedotin, and further actively explore the market space. Additionally, the application and clinical trials of product indication expansion in the pipeline will continue to accelerate.

In the international markets, the Company will further strengthen expansion while continuing to rapidly advance and begin clinical research of core products. In the United States, an international multi-center Phase III clinical trial of telitacicept in the treatment of SLE indications is being conducted along with a Phase II clinical trial for the treatment of IgAN. Regarding disitamab vedotin, the Company will continue to cooperate with Seagen Inc. to further support its global clinical trials.

About RemeGen Co. Ltd.

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The Company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases.

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