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RemeGen, Ltd. Announces Positive Results from RC48 Clinical Trial in HER2 Positive Metastatic or Unresectable Urothelial Cancer

New Data in Bladder Cancer Demonstrates Potential of Clinical Program for HER2 Cancers

Yantai, China, May 16, 2018 /PRNewswire/ -- RemeGen Ltd. today announced that new results from itsrobust oncology pipeline will be presented at the upcoming 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31- June 4, 2019.

“The poster discussion session at ASCO 2019 will feature new data from a Phase II study of RC48, a novel humanized anti-HER2 antibody-drug conjugate (ADC), for patients with metastatic urothelial cancer,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen, Ltd. “These data support the scientific view that this pathway may play a key role in the treatment of many cancers with tumors that express HER2 antigen such as gastric, breast, lung, ovarian and bladder cancers.” Amplification of the HER2 gene and overexpression of its product were first discovered in breast cancer and are significantly associated with worse outcomes.i Many studies have demonstrated that HER2 is also present in several other cancers, including colorectal, ovarian, prostate lung and particularly, gastric and gastroesophageal cancers.ii

The RemeGen 2019 ASCO Annual Meeting abstract can be found at www.asco.org:

-- Abstract No. 4509 (June 3, 2019, 4:30 - 6:00 p.m. CST): A phase II study of RC48-ADC in HER2-positive patients with local advanced or metastatic urothelial carcinoma.

About RC48
RC48 was developed to treat HER2+ solid tumors. It has a novel antibody with a higher affinity to HER2 compared to standard of care, and superior anti-tumor activity compared to other treatments in animal models. RC48 was the first ADC drug approved for human clinical trials in China and excellent safety profile has been observed in clinical trials. It is currently being studied in multiple late-stage clinical trials across solid tumor types.

About RemeGen Ltd.
RemeGen is a leading global biotechnology company dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen’s main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, RemeGen has
laboratory research facilities and offices in Beijing, Shanghai and California. It has an extensive collaboration with Tongji University, one of the top universities in China. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of development. Currently, there are two products in Phase III clinical development to treat autoimmune and oncology indications: RC18 and RC48.

Forward-Looking Statements
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the possible utility or application of the Company’s technologies to develop therapeutic agents, therapeutic potential of investigational agents, and future development activities including clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, including the risks that RemeGen Ltd. may experience delays in its planned clinical trial initiations or otherwise experience failures or setbacks in its preclinical and clinical development programs due to the potential lack of efficacy or risk of adverse events as RemeGen Ltd.’s product candidates advance in development or other factors. These factors include those discussed in RemeGen Ltd.’s public reports are available by contacting Dan Ross at danross@remegen.cn. RemeGen Ltd. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:
Marie Boyle
404.865.3590
mboyle@spectrumscience.com

Investor Contact:
Dan Ross
619.208.8439
danross@remegen.cn

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i Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse
and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177–182. ii Yan M, Schwaederle M, Arguello D, Millis SZ, Gatalica Z, Kurzrock R. HER2 expression status in diverse cancers:
review of results from 37,992 patients. Cancer Metastasis Rev. 2015;34:157–164.

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