Eisai China Holdings Ltd. signed an agreement with Liaoning Tianyi Biological Pharmaceuticals Co., Ltd. in November 2015, and Eisai China Investment Co., Ltd. purchased 100% of the shares of Liaoning Tianyi Biological Pharmaceutical Co., Ltd. Through this acquisition, Eisai will enter the generic pharmaceutical business in China in addition to expanding its existing business focused on new medicines. By further strengthening its business platform foundation established over 25 years of doing business in China and providing a stable supply of high quality generic pharmaceuticals, Eisai will be able to fulfill an even wider range of medical needs in China.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its European regional headquarters Eisai Europe Ltd. (Location: U.K.) has received a positive opinion from the European Medicines Agency‘s Committee for Medicinal Products for Human Use (CHMP) on anticancer agent Halaven® (eribulin mesylate) for treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer in the EU, this marks the second indication for which Halaven has received a positive CHMP opinion based on a statistically significant extension of OS.

The CHMP‘s positive opinion is based on the results from Phase III study (Study 309) comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study‘s primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.77 [95% CI=0.62-0.95], p=0.0169). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven, median OS: 15.6 months vs dacarbazine, median OS: 8.4 months; HR 0.51 [95% CI=0.35-0.75]).
In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven.

Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries including Japan and countries in Europe and the Americas. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Halaven has been designated as an orphan drug for soft-tissue sarcoma in the United States and Japan.

Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels). Approximately 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year or about 1% of all cancers diagnosed in Europe. Liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

Through obtaining this additional approval, Eisai aims to enhance the clinical value of Halaven to contribute further toward addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

On a stormy day on Sep. 2, 2014 as predicated by the Meteorological Forecast and Warning Center of Beijing, the staff of Eisai Pharmacy Administration Base was preparing for the “Well-being Campaign” donation to Yunzhou Central Primary School in Chicheng County with full enthusiasm and expectation. Upon entrustment by Feng Yanhui, general manager of Eisai China, the staff, all filled with the “hhc” spirit, embarked on the journey to Yunzhou Central Primary School just before dawn in spite of the rain.

The Chinese Children and Teenagers Well-being and Growth Program is a large-scale public welfare program jointly sponsored by China Children and Teenagers’ Fund and State Administration of Work Safety. Chicheng County is a national-level poverty-stricken county and also one of the targets given priority in attaining anti-poverty support. As instructed by the GM Feng Yanhui, Eisai people should participate in public welfare campaigns and help every single student with practical actions. Since this June, Eisai Pharmacy Administration Base has been maintaining intensive communication with the headmaster and teachers of Yunzhou Central Primary School through China Children and Teenagers’ Fund, and has donated books and articles for study and daily use which satisfy the actual demands of teachers and students. Among the donations, there are 279 books of different kinds that greatly enrich the categories of library books help students to expand the areas of reading and absorb more nourishment for the mind; and there are 203 packages of stationery, kettles and other articles for study and daily use that can improve the students’ studying and living qualities. Eisai hopes all the students in the school will study and grow up healthily and happily.

At the donation ceremony of Ankang Library, the students spoke with wholehearted gratitude and resolution to study hard and give back to the society. Eisai staff there was all moved by their tender and firm voices. Yamada Koki, head of the Pharmacy Administration Base said smiley that “I hope to make some humble efforts to help children and teenagers in the local area grow up healthily and happily, especially the leftover and migrant children.”

On a chilly day, the students there were seating on the playground under a gloomy sky. Though not as white-skinned and strong as children living in cities, they’re all wearing innocent and grateful smiles. Their smiles warm the hearts of all the Eisai staff there. You would never be touched to the very heart in this way if you haven’t traveled a long way to this primary school, moved so many boxes of books and stationery with your hands, heard of the children’s tender and firm voices, seen their warm smiles, and stepped inside the toilets built by bricks without flushing facilities at the corner of the playground. Deeply infected by what Eisai staff has done for them, the students know better about cherishing, gratitude and giving back. Knowing that several students need to share one computer when taking computer lessons, Yamada Koki said Eisai would offer continual concern and support for the primary school and do everything it could to help the children, in the hope that the children would develop lofty ideals, behave gratefully and give back to the society.

These books, carrying not only knowledge but also love and hope, are the gifts given by Eisai to the pupils in this impoverished mountainous area when they came back to school. Eisai has been launching “hhc” campaigns for long, and education is one of the target fields of these campaigns. In 2006, Eisai ever offered full financial support for the Supreme People’s Court to implement the “WHU Changes Destiny” program, offering subsidies of RMB 360,000 to the children of impoverished judges in Guizhou. Since 2008, Eisai has funded many scholarship programs in an array of medical colleges and universities, covering Shenyang Pharmaceutical University, Shanghai Jiao Tong University, Suzhou University, Sun Yat-Sen University, Suzhou Industrial Park Institute of Vocational Technology and Suzhou College of Medicine Science and Technology, etc. Eisai, a pharmaceutical enterprise operating in China for 23 years and valuing honoring social responsibilities as its important mission, is always ready to make due contributions to China’s public welfare programs.

(Note: the teaching building of Yunzhou Central Primary School shown in the photo is donated by benevolent public figures.)

The “Meet You on Wednesdays” platform sponsored by China International Forum of Medicine under Chinese Medical Association and co-sponsored by Eisai China Inc. was officially launched recently. It is a network interaction & learning platform on peripheral neuropathy and other relevant diseases. China International Forum of Medicine is responsible for inviting prestigious national neurologist to deliver lectures and introduce typical cases of peripheral neuropathy, aiming at improving the skills of clinicians’ of all levels in Mainland China in diagnosis and treatment of peripheral neuropathy.

Since its launch in Jul. 2012 till now, the platform has been broadcasting at 3:00 p.m. on the 2^nd Wednesday of each month. Eisai China may organize doctors or the doctors may themselves visit www.e-mbl.com to watch the videos for learning and interaction. They can explore the latest guidelines released abroad, share and exchange views on typical cases, discuss on topics of peripheral neuropathy and share their valuable experience in scholar research and clinical diagnosis & treatment, thereby enhancing mutual communication and understanding.

Osteoporosis is a latent and degenerative disease featured by high morbidity, disability rate and fatality rate. 69,440,000 persons of those aged 50 or above suffer from osteoporosis. The fatalness of osteoporotic fracture is 40% for women and 13% for men. For those suffering from osteoporotic fragility fracture on hip, 20% will die from complications of this disease, 30% become permanently disable, 40% lose the ability of independent ambulation, and 50% lose the ability of self-care after one year. Meanwhile, medical staff serving those patients has to work for long hours under tremendous pressure. What’s more, physicians are also victims of diseases. They are exposed to twice higher risk of diseases than the peers. In particular, the physicians aged 40 or above are exposed to a much higher risk of geriatric diseases than average. The medical staff who brings health and happiness to patients also requires our concern and care.

The public service activity titled “Osteoporosis-Care for Doctors” jointly sponsored by China Association of Health Promotion and Education and Eisai China Inc. was officially kicked off on May 3 in Beijing Hospital, marking the start of this large-scale public benefit campaign that will last for 3 months and cover more than 40 cities across China. Sticking to the tenet of “concern, prevention and action”, the sponsors of this activity organized lectures on osteoporosis risk screening and health knowledge for medical staff, for the purpose of enhancing medical staff’s concern on their health and helping them acquire the knowledge on osteoporosis prevention and mitigate the risk and hazard associated with osteoporosis by means of early prevention & diagnosis and regulated treatment.

Yin Dakui, president of China Association of Health Promotion and Education and former vice-minister of National Health and Family Planning Commission, and Liu Keling, standing vice-president and secretary-general of China Association of Health Promotion and Education both spoke highly of this activity. At the kick-off meeting, Wang Jianye, secretary of the Party Committee of Beijing Hospital pointed out that this activity is launched at the right moment as medical staff calls for immediate public concern and care. Pan Wei, senior manager of PC-BU Marketing Section of Eisai China primarily introduced Eisai’s hhc (human health care) concept and expressed Eisai’s resolution to offer its full support in bringing this activity to fruition.

Prof. Sun Mingxiao, deputy head of the Secretion Department of Beijing Hospital and an expert in osteoporosis, delivered a special report titled “Healthy Bone and Happy Life”, mainly introducing how to effectively prevent and cure osteoporosis. He especially recommended vitamin K2 preparation as a safe drug for improving bone quality.

Meanwhile, nearly 200 medical workers from Beijing Hospital and Tongren Hospital and 10 domestic media attended and raised questions at the kick-off meeting.

After the meeting, Prof. Sun Mingxiao said that she acquired knowledge on VK2 and osteoporosis through lectures and hoped to apply GLAKAY^® Capsules with the least delay possible to experience for herself this product’s remedies to osteoporosis. Other doctors from Tongren Hospital and Beijing Hospital present at the kick-off meeting also expressed that many medicines are available for osteoporosis but only Eisai and its GLAKAY^® products truly care for the health of medical workers. Among 121 feedback questionnaires completed and submitted by medical workers from Beijing Hospital, 110 registered and applied to get GLAKAY^® samples.

The information on this kick-off meeting was also released on www.cmt.com.cn, www.haoyisheng.com, www.idiabetes.com.cn and www.mdweekly.cn. 74 in-house lectures are expected to be held in the incoming May-July across the country, covering doctors of 5000 person-time.