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Tuesday - May 25, 2021
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Precision oncology treatment Larotrectinib submitted for marketing authorization in China

Berlin, May 25, 2021 – Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of larotrectinib in China for the treatment of adult and pediatric patients with advanced solid tumors that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Larotrectinib is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion. The product is already approved in several countries under the brand name Vitrakvi™, including the U.S., countries of the European Union (EU), and most recently Japan. Filings in other regions are underway or planned.

“There remains a high unmet need for innovative treatments for TRK fusion cancer patients in China. The filing of larotrectinib marks an important step towards treating TRK fusion cancer based on the oncogenic driver rather than the site of origin in the body,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer's Pharmaceutical Division. “In clinical studies, larotrectinib has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion cancer. We are committed to providing TRK fusion cancer patients and their treating physicians in China with this highly innovative treatment option which represents a significant advancement in the fight against this rare type of cancer.”

The New Drug Application is based on clinical trial data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung, thyroid, melanoma, colon, cholangiocarcinoma, soft tissue sarcomas, gastrointestinal stromal tumors, salivary gland and infantile fibrosarcoma. The compound has shown remarkable efficacy with high response rates and durable responses as well as a favorable safety profile across tumor types in adults and children with TRK fusion cancer. The clinical activity has been shown across multiple tumor types including primary central nervous system (CNS) tumors and brain metastases.

TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade leading to tumor growth and spread.

About larotrectinib (Vitrakvi™)
Larotrectinib is a first-in-class oral TRK inhibitor that was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset published in The Lancet Oncology and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib is approved under the brand name Vitrakvi™ in more than 40 countries around the world, including the U.S., countries of the European Union (EU), and most recently in Japan. Filings in other regions are underway or planned. In the EU, the product is approved for the treatment of adult and pediatric patients with solid tumors that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.

About TRK Fusion Cancer
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including lung, thyroid, GI cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (secretory carcinoma of the salivary gland) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma).

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. Bayer focuses its research activities on first-in-class innovations across the following scientific platforms: Oncogenic Signaling, Targeted Alpha Therapies, and Immuno-Oncology. Across the areas of focus, we have several prostate cancer treatments on the market or in development, with the goal of extending survival while limiting side effects of treatment throughout the different stages of the disease. Another key focus at Bayer is on innovative precision oncology treatments, with an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread, and another TRK inhibitor advancing through the pipeline. The company’s approach to research prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Anna Koch

Oncology
Phone +49 30 468-15942
Phone +49 214 30-72704