The Third Generation Oral Breast Cancer Drug AND019 Received FDA IND Approval

On October 1st, the third-generation oral breast cancer new drug, AND019, independently developed by Kind Pharmaceuticals LLC has received IND approval by the US FDA. This is a second innovative drug approved for clinical development after the company's leading domestic new anemia drug AND017 being approved for Phase 2 clinical trials earlier this year. This exciting addition to the pipeline further expands Kind Pharma as an international biopharmaceutical company with global development capabilities for new drugs.

AND019 is an oral third-generation Selective Estrogen Receptor Degraders (SERDs) with a novel chemical structure. Kind Pharma owns the global intellectual property rights of the chemical. The drug can revolutionarily use the body's own protein for auto-degradation, by binding with the estrogen receptor (ER) of breast cancer cells, reducing the stability of the ER, and mediating the degradation of ER by the internal proteasome pathway, to reduce the ER level and block ER signaling, achieving the purpose of inhibiting tumor cell proliferation. AND019's unique mechanism of action and extremely high ER degradation efficiency reveal its potential to completely overcome the drug resistance and side effects of other ER antagonists. It is developed as an important product of breast cancer hormone therapy, and it is anticipated to become a resolution of the current world problem of drug resistance.

The preclinical studies show that AND019 has excellent in vivo and in vitro biological activity with good oral absorption and wide therapeutic window in animal models, which allows it to be developed as a first-line treatment for breast cancer. Compared with the existing similar drugs, AND019 has better pharmacodynamics and pharmacokinetic properties, and better safety profiles. It is very convenient for administration as a capsule with high patient compliance and long-term benefits. There are currently no approved oral SERDs available for breast cancer over the world.

Dr. Dong Liu, the founder, chairman and CEO of Kind Pharma, stated that the IND was submitted to the NMPA in China and the FDA in the United States at the start of September this year. It is another new drug that the Company has effectively obtained IND approval from the US FDA after AND017. This is a new milestone for Kind Pharma, attributing to the high awe of science, perseverance, and close cooperation of the entire teams. Dr. Dong Liu said, "We will continue to promote the high-quality development of this product and keep our original intentions in mind to make our best efforts to improve human health!"

Kind Pharmaceuticals LLC was founded on July 15, 2014, by a group of scientists with years of industrial experience in large scale international pharmaceutical companies and innovative biotechnology companies. Kind Pharma is a global science-led biopharmaceutical company with its China site located at Yuhang District of Hangzhou, Zhejiang Province, and its US sited located at the Pharmaceutical Research Center in San Francisco. The Company follows the philosophy of "Kind to humans, humble to science, and good to patients", focusing on the research and development of innovative drugs. In recent years, scientists from Kind Pharma applied their profound and unique understanding of physiological hypoxia mechanisms to the development of innovative drugs that are in urgent need. The leading project is the oral small molecule compound AND017 for the treatment of anemia caused by chronic kidney disease (CKD). At present, this drug is in Phase 2 of global multi-center clinical trials in China and the United States, occupying a leading position among drugs of the same target. The Company has also completed a Series B financing and has a 300,000 square foot production facility under construction. In the future, the Company aims to deploy in the fields of kidney disease, cancer, and neurological diseases. The new drug product pipeline includes oral small molecule preparations and biomacromolecule drugs.