Double Milestone for Henlius: Raises $190M in New Financing Round and Receives CFDA IND Approval for PD-L1 Drug

2017Year12Month20Day,Fosun PharmaIssued an announcement stating that the company’s controlling subsidiaryHenlius Plans to Issue New Shares5543.510,000 shares，Fundraising Approx.1.9hundred million U.S. dollars.Participating in this"Capital Increase Agreement"except for the holding companyFosun PharmaIn addition, the Company’s other existing shareholders and the investors in this capital increase and share expansion.

It is reported that Henlius Biotech was established in February 2010, with its business scope covering the research and development of monoclonal antibody drugs, the transfer of proprietary technologies, and the provision of related technical services and consulting. From January to September 2017, Henlius Biotech achieved operating revenue of RMB 21.95 million and incurred a net loss of RMB 145 million.

According to the announcement, Fosun Pharma Industry plans to invest RMB 330 million to subscribe for 14.59 million new shares of Henlius, accounting for approximately 3.25% of Henlius’s total share capital after the completion of this capital increase and share expansion. Other investors include Chongqing GTJA, Shenzhen GTJA, Jiaxing Shenmao No. 8, Joyful Ascent Limited, Green Tomato Asia Limited, Gongqingcheng Yingshuo, and Shenzhen Yinxun Investment.

According to VCBeat, seven other external investors plan to collectively invest approximately $140 million to subscribe for 40.85 million newly issued shares of Henlius Biotech, accounting for approximately 9.09% of the total number of shares of Henlius Biotech after the completion of this capital increase and share expansion.

Henlius was established in December 2009 as a joint venture between Shanghai Fosun Pharmaceutical and a team of U.S. scientists, primarily dedicated to the research, development, and industrialization of monoclonal antibody biosimilars, biobetters, and innovative monoclonal antibodies using cutting-edge technologies. The company has a registered capital of RMB 350 million and has cumulatively invested over RMB 800 million in the early-stage research and development of monoclonal antibody drugs.

Henlius is currently developing a product portfolio primarily focused on oncology and autoimmune diseases. The core members of the company’s R&D team possess extensive experience in the early-stage development and industrialization of multiple monoclonal antibody drugs at major international pharmaceutical companies. Adhering to a product development philosophy centered on globally integrated collaborative innovation, Henlius has established R&D laboratories in Shanghai (China), California (USA), and Taipei. These facilities are equipped with internationally standardized instruments and apparatus essential for the early-stage development of monoclonal antibody drugs. Notably, the Shanghai laboratory, covering a total area of approximately 4,300 square meters, has completed the construction of its monoclonal antibody drug development platform.

To date, the company’s team has completed the efficient R&D and IND filings for 8 products covering 13 indications, positioning it at the forefront of the domestic industry. Among these, 6 products have already received clinical trial approvals from the CFDA for all 11 indications.

Among these, Henlius’ first product, HLX01 (recombinant chimeric anti-CD20 monoclonal antibody injection), received the “Notice of Acceptance of Drug Registration Application” from the China Food and Drug Administration in October 2017 for the indication of non-Hodgkin’s lymphoma, making it the first monoclonal antibody biosimilar in China to have its registration application accepted. The second indication for HLX01, rheumatoid arthritis, is also in Phase I clinical trials.

Henlius’s second product, HLX02 (“Recombinant Humanized Anti-HER2 Monoclonal Antibody”), for the indication of breast cancer, and its third product, HLX03 (“Recombinant Fully Human Anti-TNFα Monoclonal Antibody”), for the indication of psoriasis, are both currently in Phase III clinical trials. The fourth product, HLX04 (“Recombinant Humanized Anti-VEGF Monoclonal Antibody Injection”), for the indication of colorectal cancer, is in Phase I clinical trials.

It is reported that HLX07, Henlius’s first innovative bio-better monoclonal antibody, has received clinical trial approvals from both China and the United States, and Phase I clinical trials are currently underway in Taiwan.

Upon completion of this capital increase and share expansion, the Group’s shareholding in Henlius is expected to be adjusted from approximately 67.53% to approximately 62.44%, with Henlius remaining a controlling subsidiary of the Company.

On the same day the announcement was made, the Company’s independently developed new drug HLX20—a recombinant fully human monoclonal antibody injection targeting PD-L1—was accepted for clinical trial registration review by the China Food and Drug Administration (CFDA). The trial is primarily focused on the treatment of solid tumors.