 | |
Native name | 한미약품 |
|---|---|
Romanized name | Hanmiyagpum |
| Industry | Pharmaceutical |
| Founded | 1973; 52 years ago (1973) |
| Founder | Lim Sung-ki |
| Headquarters | , South Korea |
| Website | hanmi |
| Hanmi Pharm | |
| Hangul | 한미약품 |
|---|---|
| Hanja | |
| Revised Romanization | Hanmi Yagpum |
| McCune–Reischauer | Hanmi Yakp'um |
Hanmi Pharm Co., Ltd. (Korean: 한미약품 주식회사;Hanja: 韓美藥品 株式會社) is a South Koreanpharmaceutical company that is headquartered inSeoul.[1]
Hanmi was founded in 1973 by Lim Sung-ki, who was apharmacist.[2] It was originally named Lim, Sung-ki Pharmaceutical Co., but it was quickly changed to Hanmi Pharmaceutical. The company originally started sellingTrimethoprim/sulfamethoxazole powder, and would expand to produceCephalosporin antibiotics in 1985 and injectableCeftriaxone antibiotics in 1987. By 1988 the company was listed in theKorea Exchange.[3] Hanmi started selling drugs in China in 1996.[4] In 1994, the company began developingCyclosporin. The company broke the₩100,000,000,000 barrier in sales in 1997. The company began moving into the European market in 1998. The company still was developing new drugs, withPaclitaxel in 2000,Itraconazole tablets in 2001, 24-hour controlled-releaseNifedipine tablets and a new salt form ofAmlodipine in 2004, and an anti-obesity drug using sibutramine mesilate in 2007. Hanmi andCrystal Genomics formed astrategic partnership in 2008.[3]
By around 2010, Hanmi's R&D had two areas of interest: developing longer-lasting peptide and protein therapeutics using its "Lapscovery" technology, and developing small moleculetyrosine-kinase inhibitors for cancer and autoimmune diseases. Its strategy was to developmental incremental modifications of existing drugs, create newcombination drugs, and to develop novel drugs.[5][6]
In August 2014 Hanmi exclusively licensed rights in China forpoziotinib, a small moleculeEGFR inhibitor, to the Chinese company Luye Pharma; in February 2015 Hanmi licensed rights in the rest of the world outside of South Korea to Spectrum Pharmaceuticals.[5]
In March 2015 Hanmi andLilly signed an exclusive license outside of Asia for Hanmi's small moleculeBruton's tyrosine kinase inhibitor in the field ofautoimmune diseases; Lilly paid $50 million upfront and the deal included up to $640 million in milestones and royalties greater than 10%.[7]
In November 2015 Hanmi signed three agreements:
In April 2016 Hanmi announced that it had acquired land nearYantai in theShandong province of China, where it would build a manufacturing plant and R&D facility; at that time it already had a facility in Beijing.[4] In July Hanmi said it intended to invest more heavily in developing candidate substances of promising new drugs at an early stage in new pharmaceutical and biotech related fields, including through aventure capital firm set up by Sung-ki and colleagues.
In May 2016 the Korean regulatory authority approved olmutinib as a second-line treatment for certain kinds ofnon-small cell lung cancer.[2]
On September 28 Hanmi and Zentec Pharmaceuticals agreed that Zentec would market Hanmi's small molecule cancer drug candidate,HM95573; Zentec paid $80 million upfront, with $830 million in milestones, and royalties.[10]
On September 29, Hanmi andRoche's cancer subsidiaryGenentech announced a deal for Hanmi's Phase I cancer drug candidate,HM95573, which targets theMAPK/ERK pathway; Roche agreed to pay $80 million upfront, and the deal included $830 million in milestones.[11]
In December 2016 the Sanofi deal was reduced in scope, with Hanmi receiving back rights to the once-weekly insulin and the combination GLP1-RA/insulin product, and agreeing to repay Sanofi $250 million of the $434 million upfront payment.[12]
On December 3, 2019, Rapt Therapeutics and Hanami Pharmaceutical announced collaboration to develop and commercialize FLX475 in Asia.[13] FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.
In August 2020, chairman and founder of Hanmi Pharmaceutical Lim Sung-ki died of a chronic disease. He was 80.[14]
On May 15, 2023, Athenex, which was Hanmi's U.S. partner for its anticancer product, Oraxol, filed forChapter 11 bankruptcy protection.[15]
On the evening of September 29, 2016, Hanmi announced the Roche deal, causing its stock to rise; Hanmi was notified by Boehringer that evening that Boehringer was terminating their deal, and the company announced the termination on the morning of the 30th, causing its stock to crash. Hanmi's offices were raided by Korean regulatory authorities in mid-October based on evidence that insider knowledge of the Boehringer termination was passed to third parties, who shorted the stock prior to the announcement on the 30th.[1][16] In December three Hanmi employees were among 17 people indicted for insider trading; 25 people were fined, and 45 people were found to have made illegal trades that took around 3.3 billion won ($2.83 million) in profits based on the information.[17][18]
On September 30, 2016, Korean regulatory authorities issued a safety alert about olmutinib in which it described two cases oftoxic epidermal necrolysis, one of which was fatal, and a case ofStevens–Johnson syndrome; Boeheringer announced the termination its deal with Hanmi the same day, citing that the decision came after a review of "all available clinical data" on the drug, and also referring to competing drugs.[19]
In April 2018 Hanmi was found to have violated two laws in Korea by not disclosing adverse effects of olmutinib sooner.[20] In that month Zai said it was dropping olmutinib[21] and a few days later Hanmi said it was terminating development of the drug.[22]
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