Pfizer's Breakthrough Innovative Drug IBRANCE(R) (palbociclib) Receives Approval in China

World's First Kinase 4/6 (CDK 4/6) Inhibitor and Only Innovative Breakthrough Therapy for Advanced Breast Cancer in China over Past Ten Years

BEIJING, Aug. 7, 2018 /PRNewswire/ -- Pfizer China today announced that the China National Drug Administration (CNDA) has granted approval of IBRANCE^® (palbociclib) on July 31^st, the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.

IBRANCE

"We are very happy and proud to have received approval of IBRANCE® in China. IBRANCE® is the first CDK4/6 inhibitor development by Pfizer, today we are able to bring this innovation to Chinese advanced breast cancer patients to provide new hope and a new treatment option to significantly prolong their PFS and improve their life quality, which benefits the patient's family and society as well," said Wu Kun, China Country Manager of Pfizer Innovative Health.

Pfizer's IBRANCE Receives Approval in China

The 5-year survival rate of advanced BC patients is only 20%, and no significant improvement in treatment solutions has been made in the past 10 years.

Breast cancer is one of the most common cancers in women worldwide. In 2015, 272,000 women in China were diagnosed with breast cancer, and 70,000 women died of breast cancer¹. Each year, 1 in 10 newly-found cases is diagnosed as advanced breast cancer. Even among early breast cancer patients who have received surgical treatment and undergone standard therapy, 30-40% will later recurrence into advanced breast cancer.² Public awareness and understanding of advanced breast cancer remains low. In 2016, Pfizer and the European Oncology Society jointly released the Global Status of Advanced/Metastatic Breast Cancer 2005 – 2015 Decade Report, which found that in U.S., 61% of people know little about advanced breast cancer, and 48-76% of surveyed populations in 14 countries mistakenly assume that advanced breast cancer can be cured. ³

Different to early breast cancer treatment, for which there exist a variety of treatment methods, there has been no significant development in treatment solutions for advanced breast cancer in the past 10 years. The median overall survival for patients with advanced breast cancer is only 2-3 years, with only 20% 5-years survival rate. Innovative therapies are urgently needed.²

IBRANCE® is the world's first CDK 4/6 selective inhibitor, effectively prolonging the median PFS by 10 months.

IBRANCE is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.  CDKs 4 and 6 are key regulators of the cell cycle that triggers cellular cycle progression. CDK 4/6 is over-expressed in many kinds of cancer cells and causes loss of cell cycle control, which is considered a key cancer indicator. IBRANCE® is the world's first CDK 4/6 inhibitor, which restores control of the cell cycle and thus blocks the proliferation of tumor cells. In 2013, IBRANCE® received the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced breast cancer. In 2015, IBRANCE® received FDA accelerated approval for the treatment of advanced breast cancer. The US National Comprehensive Cancer Network (NCCN) Panel has included the combination of palbociclib with letrozole as a first-line endocrine therapy option for postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer ⁴.

Research indicates that IBRANCE® in combination with letrozole for the treatment of patients with HR+/HER2- resulted in median PFS of 24.8 months while 14.5 months in letrozole monotherapy arm. Compared to letrozole single-agent treatment, IBRANCE® in combination with letrozole treatment prolonged the PFS for patients with advanced breast cancer by 10 months.⁵

To date, IBRANCE® has been approved for market entry in 86 countries and regions worldwide, and China mainland is the 87^th. "As a leading pharmaceutical company in China, Pfizer strives to provide cancer patients with the latest treatments in pursuit of maximum benefits, which is an active response to government's 'Healthy China 2030' initiative and Pfizer's commitment of Working Together for a Healthier China," said Wu Kun, China Country Manager of Pfizer Innovative Health. "We are grateful to the Chinese government for adopting a broad range of measures to meet the urgent clinical needs for medication for tumor patients, and I'm thankful to every officer involved in approving IBRANCE®. This joint effort will ensure that Chinese advanced breast cancer patients experience the benefits from IBRANCE® sooner, enabling them to receive better overall treatment and enjoy a higher quality of life."

About IBRANCE®

IBRANCE® is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular cycle progression.^6,7 IBRANCE is indicated in the U.S. for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor   as initial endocrine-based therapy in postmenopausal women. ⁵

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, and redefine the survival with cancer.

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.  We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products.  Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products.  Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.  Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.  To learn more, please visit us at www.pfizer.com.

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