RemeGen's Disitamab Vedotin Achieves First-Line Treatment Recommendation Status for Advanced Urothelial Cancer in Updated 2022 CSCO Guidelines

YANTAI,China,Nov. 17,2022 -- RemeGen Co.,Ltd. ("RemeGen" or "the Company") (9995.HK,SHA:688331),a Chinese commercial-stage biotechnology company,announced on November 5 that the Company's self-developed novel antibody-drug conjugate (ADC) Disitamab Vedotin (RC48) has been officially included in the newly released Chinese Society of Clinical Oncology (CSCO) 2022 Guidelines for the Treatment and Management of Urothelial Cancer as a first-line treatment recommendation. The inclusion marks the entry of Disitamab Vedotin as a Class III recommendation for first-line treatment and a Class II recommendation for second- and third-line treatment of advanced metastatic urothelial carcinoma (mUC),making it eligible for full-line treatment of the disease.

The 2022 edition of the CSCO guidelines contains a significant update of the Pathological Diagnosis section which recommends the necessity for all patients with locally advanced or metastatic urothelial carcinoma and postoperative pathological diagnosis of primary invasive urothelial carcinoma (≥pT2) to be routinely tested for HER2,the primary target of RemeGen's proprietary novel ADC Disitamab Vedotin.

Disitamab Vedotin was previously included in the 2021 edition of the CSCO guidelines as a Class III recommended regimen for second- and third-line treatment of urothelial carcinoma. In this year's guidelines update,the recommendation level of second-line and third-line treatment of Disitamab Vedotin monotherapy has been upgraded from level III to level II. Significantly,a combination therapy of Disitamab Vedotin and Toripalimab has also been included for the first time in level III recommendations of first-line treatment and second-line treatment,which is invaluable for helping clinicians gain a clearer understanding of the application of Disitamab Vedotin for mUC.

Most notable among the first-line treatment recommendation updates is the addition of Disitamab Vedotin in combination with Toripalimab to a Class III recommendation which covers the entire urothelial carcinoma population. This is based on the excellent results of the updated RC-48-C014 study disclosed at the 2022American Society of Clinical Oncology Genitourinary (ASCO GU)Cancers Symposium and at the 2022 ASCO Congress. The study showed that the combination therapy of Disitamab Vedotin with Toripalimab in the first-line treatment of patients with mUC had an overall response rate (ORR) of more than 70% and a median progression-free survival time (mPFS) of 9.2 months. Regarding safety,the incidence of grade 3 and higher adverse events (AEs) was 36%,with the combination therapy also providing significant benefits to mUC patients under close AE monitoring.

As the first Chinese-developed novel ADC drug,Disitamab Vedotin has been recognized as a dual breakthrough therapy by the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA) for use in second-line treatment of patients with HER2-expressing,locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy. Clinical studies have shown that Disitamab Vedotin has excellent efficacy and a good safety profile in the treatment of advanced urothelial carcinoma,as a single or combination therapy,which may offer more options for the numerous patients who are facing treatment difficulties.

About CSCO

Founded in 1997,the Chinese Society of Clinical Oncology (CSCO),is a national,academic,non-profit professional academic society. The CSCO guidelines are based on evidence-based medical research,the convergence of domestic and international clinical research results and new advances in precision medicine,considering regional differences in development,the availability of drugs and treatment methods,and are among the most authoritative guidelines for the diagnosis and treatment of tumors in China.

About RemeGen Co. Ltd.

Founded in 2008,RemeGen (9995.HK,SHA: 688331) is a leading biopharmaceutical company inChinacommitted to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughoutChinaandtheUnited 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.

For more details,please visit:www.remegen.cn