Takeda Announces National Commercial Launch of Mobocertinib Capsules for EGFR Exon20 Insertion+ NSCLC in China

On April 15, 2023, the 29th National Cancer Prevention and Control Publicity Week officially kicked off in China. During this period, Takeda China announced the grand commercial launch of its innovative lung cancer drug Mobocertinib Succinate Capsules (hereinafter referred to as "Mobocertinib") across the country. This product is currently the first and only approved oral targeted therapy in China specifically for EGFR Exon 20 Insertion Mutation (EGFR ex20ins) in advanced Non-Small Cell Lung Cancer (NSCLC). Its launch fills a long-standing gap in clinical treatment in this field, marking the entry of EGFR ex20ins NSCLC into a new era of targeted therapy in China for the first time, bringing new hope for patient survival. Thousands of lung cancer experts from twenty regions across China participated in this grand event and actively joined the "Breakthrough EGFR ex20ins Savior Initiative" launched by Takeda China during the Cancer Prevention and Control Publicity Week, calling on society to strengthen attention towards rare mutation-driven lung cancers.

"Breakthrough EGFR ex20ins Savior Initiative" Launch Ceremony
Senior Vice President of Takeda Global and President of Takeda China, Guohong Shan, stated: "We are delighted to share the great news of Mobocertinib's official launch in China during this year’s Cancer Prevention and Treatment Awareness Week. The oncology field is one of Takeda's core global therapeutic areas, and we will actively leverage our R&D strengths in related fields to accelerate the introduction of innovative global treatment solutions. We are committed to supporting the 'Healthy China 2030' goal of improving the five-year cancer survival rate. In the field of lung cancer, Takeda focuses on the unmet needs of patients with non-small cell lung cancer having rare targets. Over the past year, we have introduced two globally innovative drugs, providing clinical experts with more powerful tools to tackle lung cancer. At the same time, we will continue to collaborate with all parties in the industry to enhance disease awareness of rare targets in lung cancer, actively promote the concept of precision diagnosis and treatment for lung cancer, and work together to improve the survival rate and quality of life for lung cancer patients in China."

Sean Shan, Global Senior Vice President of Takeda Pharmaceutical Company Limited and President of Takeda China

Academician Jinming Yu, an academician of the Chinese Academy of Engineering and president of Shandong Cancer Hospital, stated: "In recent years, with the continuous development of cutting-edge medical technologies, the diagnosis and treatment of lung cancer in China have greatly improved. However, there are still some patients with rare or refractory positive targets who do not have access to targeted treatment options. I am very pleased that during this year's Cancer Prevention and Control Awareness Week, the first targeted therapeutic drug for EGFR Exon 20 insertion mutation-positive advanced NSCLC has officially entered China, completely breaking the two-decade-long困境 where patients with this specific target had no specific targeted drugs available, bringing new hope to many Chinese lung cancer patients."

Academician Jinming Yu, President of Shandong Cancer Hospital and Academician of the Chinese Academy of Engineering

Major Breakthrough in 20 Years: A New Era of Targeted Treatment for EGFR ex20ins NSCLC

Lung cancer is the leading type of cancer in China. The latest national cancer statistics from the National Cancer Center show that lung cancer ranks first in both new incidence and mortality rates of malignant tumors. Among these, the incidence of advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations accounts for approximately 2.3% of all NSCLC cases in China, making it the third most common EGFR mutation. Due to the unique structure of the target site, there has been no targeted treatment specifically for EGFR exon 20 insertion mutations over the past two decades. Clinical treatment mainly relies on chemotherapy, and patients face a high degree of malignancy with worse survival prognosis compared to patients with common EGFR mutations. According to real-world data, the 5-year survival rate of patients with advanced EGFR exon 20 insertion mutations is only 8% in the absence of effective targeted therapies. There is an urgent unmet clinical need for targeted therapeutic drugs.

Mobocertinib, the first oral targeted drug developed by Takeda China in global synchronous development for EGFR exon 20 insertion mutations, has broken the chemotherapy-dominated treatment paradigm that has persisted in this field for the past two decades, offering new hope for patient survival. According to clinical study results, after 25.8 months of long-term follow-up, mobocertinib increased the median progression-free survival (mPFS) to 7.3 months and extended the median overall survival (mOS) to 20.2 months in platinum-chemotherapy pretreated patients.

Professor Wu Yilong, Honorary Director of the Guangdong Lung Cancer Institute and Lifetime Director of Guangdong Provincial People's Hospital, stated: "For EGFR gene mutations, targeted drugs are widely considered to be more effective in clinical practice with fewer side effects. Compared to traditional chemotherapy, specific targeted drugs offer significant advantages in improving patient survival and quality of life. The launch of Mobocertinib provides a new targeted treatment option for patients with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer, extending their lives while also enhancing their quality of life, bringing greater benefits to patients."

Professor Wu Yilong, Honorary Director of Guangdong Lung Cancer Institute and Lifetime Director of Guangdong Provincial People's Hospital

Professor Cai-Cun Zhou, Director of the Oncology Department at Shanghai Pulmonary Hospital affiliated with Tongji University, stated: "The launch of Mobocertinib is of epoch-making significance. According to clinical research results, previously treated patients with EGFR exon 20 insertion mutation (EGFR ex20ins) advanced non-small cell lung cancer (NSCLC) who received platinum-based chemotherapy had a median overall survival of nearly two years after being treated with Mobocertinib. The overall response rate (ORR) reached 35%, the disease control rate (DCR) was as high as 78%, and the median duration of response (mDoR) assessed by IRC was 15.8 months. These are very encouraging data, demonstrating the importance of Mobocertinib in treating patients with EGFR ex20ins mutations. I hope that Mobocertinib will serve more patients in China and usher in a new era of targeted therapy."

Professor Cai-Cun Zhou, Director of the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University
Cancer Prevention Week Launches Special Science Popularization Campaign, Calling for Increased Attention to Rare Target Lung Cancer from All Sectors of Society

According to experts, compared with common EGFR sensitizing mutations, the awareness of EGFR ex20ins mutations among medical professionals and the public in China still needs improvement. Moreover, before the adoption of more sensitive next-generation sequencing methods, EGFR ex20ins mutations were rarely focused on in clinical testing. This has led to patients being easily misdiagnosed, and their urgent clinical needs have not received sufficient attention from all sectors of society.
In response to this phenomenon, and to further enhance public awareness and understanding of relevant targets, at the launch of this year's Cancer Prevention and Treatment Awareness Week, Takeda China initiated the "Breakthrough EGFR ex20ins Savior Campaign." The campaign aims to recruit disease awareness and care ambassadors across China. With the collective efforts of these ambassadors, the initiative hopes to provide scientific, professional, and accessible education on rare mutation targets such as EGFR ex20ins in lung cancer, promote the concept of early diagnosis, early treatment, and genetic testing, and further improve diagnostic and treatment standards for related targets. This effort seeks to provide tangible support and assistance to patients with rare mutation target lung cancer through concrete actions. Additionally, by gaining a deeper understanding of the real-life conditions, symptom burdens, and clinical needs of patients, the campaign aims to empower healthcare professionals, patients, and society as a whole to overcome the challenges posed by the disease.
Takeda Fully Expands into Lung Cancer Field, Accelerating Benefits for Chinese Patients

Takeda's Multi-Year Layout in Oncology: Five Products Launched in China, Covering Multiple Treatment Areas in Hematological and Solid Tumors. The field of lung cancer is an important new area that Takeda has pioneered in China. In the past year, Takeda has successively introduced two innovative drugs for the treatment of ALK-positive non-small cell lung cancer (brigatinib) and EGFR ex20ins-positive advanced non-small cell lung cancer (mobocertinib), officially marking Takeda's "Year One of Lung Cancer" in China. Notably, brigatinib was rapidly included in the 2022 National Reimbursement Drug List (NRDL) within less than a year of its approval. Mobocertinib also set a new record for Takeda China by achieving commercial availability in just 35 working days after its swift approval through global synchronized development and submission. This accelerated the delivery of globally innovative treatment options to NSCLC patients with rare targets who still have unmet needs.

As a global digital biopharmaceutical company driven by values and research and development, Takeda has been committed to the Chinese market for nearly three decades, making China an essential part of Takeda Pharmaceutical’s global strategy. Especially in the past five years, China has played a significant role in driving Takeda's global business growth. Since 2020, Takeda China has launched the "Takeda Future Gathering" five-year development plan, announcing that it will introduce over 15 innovative products by 2025, benefiting 10 million Chinese patients. To date, including Mobocertinib, 10 of these innovative drugs have been successfully launched.

In 2022, Takeda further proposed the "Expand China" strategy to further tap into China's innovation potential, promote closer cooperation between the Chinese market and other regions of Takeda globally, and help Takeda accelerate in China's innovative opportunities. By 2030, China is expected to become the second-largest market for Takeda Pharmaceutical Company Limited globally. In the future, Takeda will continue to focus on promoting business development in the Chinese market, accelerate the introduction of more innovative drugs to the market, benefiting Chinese patients.