HuaHao Zhongtian and Luye Pharma Announce Collaboration on Commercialization of Utidelone (YouTiDi®) in Mainland China

February 21, 2022, Beijing—Beijing Huahao Zhongtian Biopharmaceutical Co., Ltd. (Huahao Zhongtian) announced that its wholly-owned subsidiary, Chengdu Huahao Zhongtian Pharmaceutical Co., Ltd., has entered into an agreement with Yantai Luye Pharmaceutical Trading Co., Ltd., a wholly-owned subsidiary of Luye Pharma Group. The two parties have reached an agreement on the natural microbial small-molecule anti-tumor drug and National Class 1 new drug, Utidelamide.^®(Generic Name: Utidelone Injection) Collaborative promotion across 26 provinces in mainland China.

Utidelone is the first domestically developed epothilone-based innovative anti-tumor drug in China, independently researched and developed by Huahao Zhongtian. It was approved for marketing by the National Medical Products Administration in 2021 for the treatment of recurrent or metastatic advanced breast cancer. Currently, this drug has been included in the "CSCO Breast Cancer Diagnosis and Treatment Guidelines (2021 Edition)" and the "Chinese Guidelines for Standardized Diagnosis and Treatment of Advanced Breast Cancer (2020 Edition)." In addition, clinical studies related to multiple new indications for utidelone are underway, involving the treatment of various advanced solid tumors such as non-small cell lung cancer, gastrointestinal tumors, gynecological tumors, and head and neck tumors.

“As the first and only approved epothilone-class antineoplastic drug in China, Utidelone has broken the long-standing bottleneck in the treatment of advanced breast cancer in our country, achieving a new breakthrough in the field of breast cancer chemotherapy over the past three decades,” stated Dr. Tang Li, Chairwoman of Huahao Zhongtian. “We are delighted to collaborate with Luye Pharma on the market promotion of Utidelone. With years of deep engagement in oncology, Luye Pharma boasts extensive market coverage and channel resources. We look forward to working together to create a win-win partnership model that leverages complementary strengths and fosters synergistic development, thereby enabling Utidelone to benefit more patients. We also extend our gratitude to our shareholder, Tianchuang Capital, for facilitating the discussions that led to this collaboration.”

“Upholding the philosophy of ‘patient-centricity,’ Luye Pharma is committed to making unremitting efforts to address patients’ unmet health needs. Oncology is one of our long-term strategic focus areas, and we look forward to achieving broader and deeper market access for utidelone, thereby tangibly helping more cancer patients.” Yang Rongbing, President of Luye Pharma Group, stated, “Utidelone also serves as a valuable addition to Luye Pharma’s oncology product portfolio, further strengthening our strategic advantages in this field.”

Utidelone^®(Generic Name: Utidelone Injection) Independently developed by Huahao Zhongtian, it is an epothilone derivative produced by genetically engineered bacteria developed through combinatorial synthetic biology technology. It represents a novel class of non-taxane anti-tumor agents that inhibit microtubule depolymerization by inducing and promoting tubulin polymerization, thereby inhibiting mitosis and triggering apoptosis to suppress tumor cell survival.

Utidelone was approved for marketing by the National Medical Products Administration in 2021, with the indication: “Utidelone in combination with capecitabine is indicated for patients with recurrent or metastatic breast cancer who have previously received at least one chemotherapy regimen, which should have included an anthracycline or a taxane.”

Phase III clinical trial results of utidelone in the treatment of advanced breast cancer have demonstrated its superior efficacy and safety: compared with standard regimens, utidelone significantly prolonged overall survival, while nearly doubling both the objective response rate and the time to disease progression. These findings were selected for oral presentation at the ASCO Annual Meeting twice and published in the prestigious international oncology journals *The Lancet Oncology* and *Annals of Oncology*. Furthermore, preclinical studies have indicated that utidelone exhibits robust antitumor activity against common malignancies, including breast, lung, liver, gastric, esophageal, colorectal, and prostate cancers, and shows considerable efficacy in tumors resistant to chemotherapy agents such as paclitaxel.

Beijing Huahao Zhongtian Biopharmaceutical Co., Ltd. (Huahao Zhongtian) is a national high-tech enterprise founded in 2002 by a team of Chinese scientists who returned from the United States, led by Dr. Tang Li and Dr. Qiu Rongguo. Leveraging an advanced combinatorial biosynthesis technology platform, the company focuses on developing novel natural microbial small-molecule anticancer drugs with independent intellectual property rights. Huahao Zhongtian’s robust product development pipeline includes the clinical development of utidelone injection for additional oncology indications, the development of oral formulations of utidelone and its domestic and international rights, as well as a series of original anticancer drug candidates—BG18, BG22, BG44, BGM57, BGMT8, and BGLP1—with diverse targets and mechanisms of action.

Luye Pharma Group is an international pharmaceutical company dedicated to the research and development, manufacturing, and commercialization of innovative drugs. With R&D centers established in China, the United States, and Europe, Luye Pharma has more than 30 drug candidates under development in China and over 10 overseas. In the fields of central nervous system (CNS) disorders and oncology, multiple innovative formulations and new drugs have already initiated registration and clinical studies in Europe, the United States, and Japan. Luye Pharma has achieved internationally advanced capabilities in advanced drug delivery technologies, including microspheres, liposomes, and transdermal drug delivery systems, and has actively laid out and developed pipelines in areas such as biological antibodies, cell therapy, and gene therapy.

Luye Pharma has strategically established a comprehensive global supply chain, operating eight manufacturing bases and more than 30 production lines worldwide, along with a GMP quality management and control system aligned with international standards. The company currently markets over 30 products spanning therapeutic areas such as oncology, central nervous system disorders, cardiovascular diseases, and digestion and metabolism. Its business presence extends to more than 80 countries and regions, covering major pharmaceutical markets including China, the United States, Europe, and Japan, as well as rapidly growing emerging markets worldwide.