Henlius Biotech recently expected to raise USD 190 million by issuing 55,434,678 new shares, pushing the company's market capitalization to more than CNY 10 billion.
Since its founding in 2009, Henlius Biotech has been abiding by the core values of "Quality, Speed, and Innovation" in an environment of fierce competition and the buoyant growth of mAb drugs. Furthermore, through incessant innovation and upgrades based on its accumulated experience in the development of biosimilars, the company built an advanced technical platform for R&D and the industrialization of antibody drugs, becoming a leading Chinese manufacturer of mAb biological drugs.
After 8 years of unremitting efforts, Henlius Biotech has successfully broken down the barriers that major international pharmaceutical companies' technical monopolies have placed in the field of mAb drug development, and built up complete core competencies that rival international standards in research, development, and manufacturing. At the end of 2015, Henlius Biotech constructed a research and industrialization base for an antibody drug pilot, equipped with state-of-the-art single-use bioreactors and core technologies in line with GMP standards. In 2016, the pilot successfully earned the EU Qualified Person (QP) accreditation and became eligible for providing samples for the clinical trials of 4 projects in EU.
In order to meet the needs of industrialization & upgrade, the company signed a project investment agreement with Shanghai Songjiang District Government at the end of 2017 to build a biological drug industrialization base (2) in Songjiang District, Shanghai. The new modern smart pharmaceutical base will boost the company's product development efficiency and production capacity to the benefit of patients, on the basis of Henlius Biotech's existing antibody drugs pilot research & industrialization base in Shanghai Caohejing Hi-tech Park.
Henlius Biotech's globalization strategy has achieved noteworthy results by virtue of the complementary technological superiority of Mainland China, Taiwan China, and California. To date, the company has completed the clinical trial submissions of 9 products for 16 indications; three products are now in Phase III of the clinical trials.
The company's first product, HLX01 (Rituximab Injection), was accepted by the China Food and Drug Administration (CFDA) in October 2017 for drug registration application review. Hopefully, it will be the first biosimilar drug available in the Chinese market and benefit more patients, including those who cannot afford expensive brand name drugs.
Henlius Biotech's HLX02 (Trastuzumab Biosimilar) received Phase III clinical trial approval in Ukraine in June 2017. It was the first Chinese biosimilar product to begin clinical trials outside of China. In September and November of the same year, HLX02 successively received Phase III clinical trial approval in Poland and the Philippines. Its multi-center clinical trials were carried out internationally. (For more enrollment information, see -- Benefits for Breast Cancer Patients | International Multi-center Clinical Trial Enrollment in Progress!) In December 2017, Henlius Biotech and Jacobson Pharma signed a letter of intent regarding their cooperation on HLX02. Jacobson Pharma received an exclusive license for the R&D, utilization, sale, offer for sale, import & export, and other commercial actions of HLX02 in Hong Kong and Macao.
HLX03 (Adalimumab Biosimilar) is the third monoclonal antibody drug independently developed by Henlius Biotech. HLX03 received clinical trial approval from the CFDA in April 2017 for the indication of psoriasis (PS), making Henlius Biotech the first of Chinese Adalimumab biosimilar drug developers to start Phase III clinical trials for a drug intended for the indication of psoriasis. Clinical trial enrollment for the drug is currently ongoing. (More enrollment information -- Benefits for Psoriasis Patients | Multi-center Clinical Trial Enrollment in Progress!)
Moreover, Henlius Biotech is gradually shifting its business from the development of biosimilars to the development of innovative mAbs, and its R&D of innovative products is advancing steadily. HLX07 (Anti-EGFR mAb), the first innovative mAb product of Henlius Biotech, received clinical trial approval in Mainland China, Taiwan China, and USA successively in 2016. In Taiwan China, Phase I clinical trials of the drug are currently ongoing. In 2017, Henlius Biotech's innovative products HLX06 (Anti-VEGFR2 mAb) and HLX10 (Anti-PD-1 mAb) received clinical trial approval from the United States Food and Drug Administration (USFDA) and the Taiwan Ministry of Health and Welfare and successfully achieved regulatory submissions in three places. In December 2017, the clinical trial application for HLX20 (Anti-PD-L1 mAb) was accepted by the CFDA, making Henlius Biotech one of the few Chinese companies that concurrently have anti-PD-1 mAb and anti-PD-L1 mAb in their product lines.
Looking towards the future, Henlius Biotech will continue its plans for globalization and will bring its business in line with the EU's quality standards. It will also rigorously push the development and industrialization of mAb biosimilars and innovative mAbs, to market more and better blockbuster mAb drugs both in China and outside China in order to implement affordable innovation. Meanwhile, Henlius Biotech will continue to develop more than ten innovative mAb biological drugs to which it holds independent intellectual property rights, in keeping with the company's strategy for combination therapy of tumors to bring patients more and better products.