Overview

Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China, focusing on the development, manufacturing, and marketing of active pharmaceutical ingredients (APIs) and finished formulations. Qilu has 12 subsidiaries and 10 manufacturing sites worldwide. In 2910 it ranked eighth in the Chinese pharmaceutical industry by sales revenue. The company is actively looking for partnerships with global colleagues via in-/out-licensing and a co-development strategy.

Global investment and collaboration

In 2020, Qilu entered an exclusive licensing agreement with Sense Bio, a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer. Under the terms of the deal, Sesen granted Qilu an exclusive license to develop and commercialize Vicineum in China. Sesen will receive an upfront payment of US$12 million and is eligible to receive up to an additional US$23 million in technology transfers and regulatory milestone payments.

The same year, Qilu reached another exclusive licensing and collaboration agreement with Quantum Genomics, a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat difficult to treat/resistant hypertension. Qilu will receive exclusive commercialization rights to Firibastat for the treatment of difficult to treat/resistant hypertension in China. Additionally, Qilu plans to join global studies of difficult to treat/resistant hypertension in China. Quantum Genomics will receive upfront and milestone payments amounting to up to US$50 million, plus double-digit royalties on sales.

R&D

Qilu has more than 2000 scientists spread across five R&D platforms worldwide. Its R&D team focuses on the research and development of generic and innovative small and large molecule drugs covering the following therapeutic areas:

• Oncology
• Adjuvant Oncology
• Cerebrovascular and Cardiovascular System
• Neurology
• Infectious Diseases

The team covers early-stage development, API and formulation research, clinical studies, global regulatory affairs, and business development.

Qilu has three US-based R&D centers based in Seattle, WA; Boston, MA; and San Francisco, CA. With a strong biotechnology background, experience, and resources, the US R&D centers are now responsible for R&D in innovative biologics.

Recently opened in the Zhangjiang District of Shanghai, the Qilu Shanghai Institute of Innovative Pharmaceutical R&D will leverage the great potential and pharmaceutical resources in the Chinese economy capital, undertaking more innovative research programs.

Products and Market

Qilu has launched 200+ products with 30+ products that were “first to launch” in China and 3 products that were “D181 launch” in the US. It has a robust pipeline, including 200+ generic products, 20+ biosimilar products, and 50+ innovative products.

The company is the first Chinese company to obtain USFDA and EDQM approval for sterile APIs. Its finished formulations and APIs have been approved by the USFDA, European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) of Australia, Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, PMDA of Japan, and other countries. Qilu has been the world’s primary supplier of Cephalosporin, β-lactam inhibitors, Amikacin and Carbapenem for over a decade.

Qilu processes a comprehensive global sales network covering both North and South America, Europe, Asia, Australia, New Zealand, CIS (Commonwealth of Independent States) countries, South Africa, and the Middle East.

Products and Market

Luye Pharma is developing a global supply chain of 7 manufacturing sites with over 30 production lines, thus establishing GMP quality management and international standard control systems. With more than 30 products covering the central nervous system, oncology, cardiovascular system, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets – China, the U.S., Europe and Japan, as well as in fast-growing emerging markets.