Results demonstrated a clinically meaningful response and survival benefit for heavily treated patients with unmet need

YANTAI, China (June 17, 2020) – RemeGen, Co., Ltd. announced positive results from its Phase II study of RC48 (disitamab vedotin) for the treatment of HER2-expressing advanced or metastatic gastric cancer in heavily treated patients at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO), which was held on May 29-31, 2020. RC48 (disitamab vedotin) is a novel humanized anti-HER2 antibody drug conjugate (ADC) developed to treat several cancer diseases.

“For the third year in a row, we are pleased to showcase clinical progress of RC48 in a broad range of solid tumor treatments at ASCO,” said Jianmin Fang, Ph.D., founder and CEO of RemeGen Co., Ltd., “We are encouraged to see positive data from the latest research, and we believe that RC48 has the potential to redefine treatment for patients with HER2-expressing advanced or metastatic gastric cancer.”

The single-arm Phase II multicenter clinical study conducted in China was designed to evaluate the efficacy and safety of RC48. The study enrolled 127 patients (IHC2+ including FISH+ and FISH-, and IHC3+) with advanced or metastatic gastric cancer including gastric or gastroesophageal junction adenocarcinoma. The key endpoint of the study was the objective response rate (ORR) of the main efficacy index evaluated by the independent efficacy evaluation committee (IRC). The confirmed ORR was 23.6%, with a median progression free survival period (mPFS) of 4.1 months. The median overall survival time (mOS) was 7.5 months.

All patients evaluated in the study had received 2 or more lines of chemotherapy treatments with a subgroup of patients having received an additional line of systemic therapy treatment such as Herceptin. The study also included patients with low expressing HER2 (IHC2+ / FISH-) tumor, potentially widening the population of patients who may benefit from this therapy. The results of the study demonstrate RC48’s potential in addressing the urgent unmet medical need for this heavily treated patient population.

More information around these findings are found in the virtual scientific program of the ASCO Annual Meeting (Abstract #4560).

About RC48

RC48 was developed to treat HER2 expressing 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 favorable 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 Co., Ltd.

RemeGen Co., Ltd. (“RemeGen”) is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen Co., Ltd.'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, China, RemeGen Co., Ltd. has labs/offices in Beijing and California. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of clinical development. Currently, there are two products in late stage clinical development to treat autoimmune and oncology indications.

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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 Co., 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 Co., Ltd.'s public reports are available by contacting Dan Ross at RemeGen Co., 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.


Jenn Gordon

Dan Ross