HONG KONG – Samsung Bioepis Co. Ltd. has inked a deal for the mainland China market with investment firm C-Bridge Capital Partners LLC, which will generate a new company: Affamed Therapeutics. The licensing agreement covers multiple biosimilar candidates from Samsung Bioepis. This includes its third-wave biosimilars SB-11 and SB-12, which are ranibizumab and eculizumab candidates based on Genentech Inc.'s Lucentis and Alexion Pharmaceuticals Inc.'s Soliris, respectively.
SB-11 is currently in phase III trials, while SB-12 is in phase I trials. Ranibizumab is a treatment for the wet type of neovascular age-related macular degeneration. Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
The deal also includes the Incheon, South Korea based biotech company's SB-3, a trastuzumab biosimilar candidate for treating breast cancer.
As part of the agreement, C-Bridge will set up a new biopharmaceutical company called Affamed Therapeutics. Through this company, C-Bridge will collaborate with Samsung Bioepis on the stages of clinical development, regulatory registration and commercialization in China.
Besides an upfront payment, Samsung Bioepis will also receive royalties on sales. Further financial details were not disclosed.
"We are proud to have partnered with established leaders at the forefront of the Chinese biopharmaceutical industry. With strong local partners in C-Bridge and 3Sbio, we believe we are optimally positioned to help meet the need for high-quality biologic medicines across China," Mingi Hyun, a spokesperson for Samsung Bioepis, told BioWorld Asia.
Just last month, the company entered a deal with China's 3Sbio Inc. for a number of its biosimilar candidates, including SB-8, a biosimilar to Avastin (bevacizumab, Genentech Inc./Roche AG). The drug candidate is undergoing phase III trials currently and has potential for a number of indications. Samsung Bioepis and the Shenyang, China-based 3Sbio will collaborate across several areas, including clinical development, regulatory registration and commercialization in the China market.
"If approved, we believe our biosimilar candidates will have strong potential to play an important role in the Chinese health care system, as evidenced in what our biosimilars have begun to do in a growing number of countries across the world," said Hyun.
The head of Samsung Bioepis concurs.
"C-Bridge is the right partner for this mission as evidenced in its exceptional track record of successfully turning portfolio companies like Affamed Therapeutics into leading biopharmaceutical companies in China and beyond," Christopher Hansung Ko, the president and CEO of Samsung Bioepis, said in a statement.
He added that they will be "further strengthening" the company's pipeline and widening their availability for patients and health care systems across the world.
"In Europe, for instance, we have four biosimilars approved and marketed. And, at the moment, we have over 100,000 patients being treated with our biosimilars. That's over 6 million doses administered in Europe," said Hyun.
In the EU, Samsung Bioepis has four biosimilars approved and marketed. These include its anti-TNF trio of Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab). It also has the oncologic biosimilar Ontruzant, a trastuzumab candidate.
In the U.S., the company has an infliximab-abda biosimilar, Renflexis, on the market. Its Ontruzant (a trastuzumab-dttb candidate) was also just approved by the FDA last month.
Also, a BLA for its SB-5 (adalimumab) biosimilar candidate is presently under FDA review.
Hyun mentioned that Samsung Bioepis will continue to examine partnership opportunities in other territories as its biosimilar pipeline continues to expand.
"We aim to partner with companies whose expertise best match the capability requirements to drive the uptake of our biosimilars," said Hyun.
Besides biosimilars, Samsung is also working on SB-26, a ulinastatin-fc fusion protein biologic candidate in phase I trials.