資料來源：https://www.wsj.com/articles/samsung-affiliate-seeks-european-approval-for-near-replica-of-herceptin-1475546455?mod=trending_now_5

SEOUL—Samsung Group’s biologic-drug-manufacturing arm on Tuesday gave new details of an initial public offering that could value Samsung BioLogics Co. at up to $8.2 billion, as its drug-development subsidiary sought regulatory approval for a new cancer treatment.

Samsung BioLogics, which is 47.8%-owned by Samsung Electronics Co.SSNHZ0.00%, the South Korean conglomerate’s crown jewel, said Tuesday in a regulatory filing that it would sell 16.5 million shares priced at between 113,000 won and 136,000 won ($102.50 and $123.17) apiece, raising $1.7 billion to $2 billion and valuing the company at as much as $8.2 billion.

Samsung Bioepis Co., a subsidiary of Samsung BioLogics that develops biosimilars, or near-replicas of biologic drugs that are made from living cells, said that it had submitted a near-replica of blockbuster breast-cancer drug Herceptin for regulatory approval in Europe.

The dual developments underscore the South Korean conglomerate’s growing ambitions in the nascent field of biologic drugs and, in particular, biosimilars, which are akin to generic copies of simpler chemical drugs such as aspirin.

While Samsung Bioepis develops biosimilars of existing drugs whose patents have expired or will expire soon, its parent company Samsung BioLogics is a contract manufacturer of biologic drugs developed by companies such as Roche Holding AGRHHBY0.41% and Bristol-Myers Squibb Co.BMY-0.22% It has also been contracted to manufacture biosimilars for Samsung Bioepis.

Samsung BioLogics is 52.1%-owned by the Samsung Group’s de facto holding company, Samsung C&T Corp.0282601.00% Samsung BioLogics, in turn, owns 91.2% of Samsung Bioepis.

Samsung BioLogics’s offering could become South Korea’s third-largest IPO on record, according to Dealogic. Still, it might have to share the spotlight with Doosan Bobcat Inc., a maker of construction equipment that is planning to list its shares on the Korea exchange late this month. The company has said it plans to raise as much as $2.2 billion.

Samsung BioLogics said it would use proceeds from its IPO to finance the construction of a third large-scale manufacturing plant, as well as for additional investment in Samsung Bioepis, expansion of its business portfolio and for general working-capital purposes.

The company plans to launch its IPO roadshow on Oct. 17 and list its shares on the main board of the Korea stock exchange on Nov. 10.

Citigroup Inc.,C2.31%Credit Suisse Group AGCS1.61%, J.P. Morgan ChaseJPM1.85% & Co., Korea Investment & Securities Co. and NH Investment & Securities Co.005940-1.20% are handling the Samsung BioLogics IPO.

Meanwhile, Samsung Bioepis’s application on Tuesday to the European Medicines Agency, which oversees the drug approval process in Europe, will be its fifth biosimilar candidate submitted to European regulators.

All five are based on drugs that were among the top 10 best-sellers by revenue last year. Herceptin brought in about $6.8 billion in sales last year, according to market-research firm FirstWord Pharma.

European regulators have already approved Samsung’s near-replicas of two rheumatoid-arthritis drugs this year.

Samsung is now selling biosimilars of those drugs, Pfizer Inc.PFE0.37%’s Enbrel and Johnson & JohnsonJNJ-0.19%’s Remicade, in Europe, at a discount to the branded originals. In the case of the Enbrel copy, which Samsung is selling in partnership with Biogen Inc.,BIIB-0.50% Samsung is selling its drug for about half the cost of the original in some countries.

In May, Samsung Bioepis submitted its Remicade biosimilar for U.S. Food and Drug Administration approval, its first foray into the world’s biggest drug market.

So far, Samsung Bioepis has focused its efforts on rheumatoid-arthritis drugs, which have the biggest market globally. Its attempt to create a drug that mimics Herceptin, a breast-cancer drug developed by Genentech, a unit of Roche, pushes it into new territory. If approved, Samsung would sell the treatment through MerckMRK0.38% & Co., which is known outside the U.S. and Canada as MSD.

Samsung Bioepis isn’t the only biosimilar developer jockeying for position since Herceptin’s main patent expired in Europe two years ago.

In late August, MylanMYL-0.33% NV and Biocon Ltd.EQBIOCON0.88% submitted the first application for European approval of a Herceptin biosimilar.

Corrections & Amplifications:

Samsung C&T Corp. owns 52.1% and Samsung Electronics Co. owns 47.8% of Samsung BioLogics Co. An earlier version of this article incorrectly stated that Samsung C&T owns 51% and Samsung Electronics owns 46.8% of Samsung BioLogics.