GC Biopharma Corp’s eight-year endeavor has finally come to fruition as its blood product successfully enters the U.S. market. This achievement marks the first Korean blood product and the seventh new drug to receive approval from the U.S. Food and Drug Administration (FDA).On Dec. 18, GC Biopharma
We raise our TP on Hanmi Pharm to W430,000. In 1Q23, both consolidated and non-consolidated earnings surpassed consensus, hitting record quarterly figures. Moving ahead, COGS-to-sales ratio should continue to improve thanks to increased sales of Rolontis and other products. We also draw attention to
Samsung Bioepis's biosimilar Renflexis, SK Biopharmaceuticals' epilepsy drug Xcopri, and Daewoong Pharmaceutical's botulinum toxin Nabota, are expected to exceed US$200 million in U.S. sales this year.The Renflexis sales added up to US$196 million last year. According to industry sources
Hanmi Pharmaceutical's U.S. partner Spectrum announced in a press release on Jan. 31 that sales of Rolvedon (product name in Korea: Rolontis), which was launched across the United States in October 2022, reached US$10 million in three months.Spectrum said in the press release that 70 clients hav
Hanmi Pharmaceutical has obtained U.S. approval for its neutropenia treatment Rolontis, opening a new chapter in its R&D history. It is the first drug that Hanmi has succeeded in commercializing in the global market.Spectrum Pharmaceuticals, a U.S. partner to which Hanmi Pharmaceutical licensed out
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed. Recommend BUY, target price of KRW380,000 We recommend BUY and TP of KRW380,000 on Hanmi Pharm. We highlight the 2Q22 earnings surprise, steady 2H22 growth forecasts for Korea/China, the release schedule of cl
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Hanmi Pharm posted consolidated 2Q22 sales of W316.5bn and OP of W29.6bn, with OP coming in slightly below our estimate. Beijing Hanmi led consolidated OP growth, booking OP of W17.1bn. The strength
The U.S. Food and Drug Administration (FDA) will make a decision on awarding marketing approval for Rolontis, the first new biotech drug candidate of Hanmi Pharmaceutical, in September. According to the FDA’s Prescription Drug User Fee Act (PDUFA), Rolontis’ approval deadline is set at Sept. 9.The F
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Hanmi Pharm posted consolidated 1Q22 sales of W321.1bn and OP of W38.7bn, in line with our estimates, thanks to Beijing Hanmi and business normalization amid the easing of the Covid-19 pandemic. Glob
Hanmi Pharmaceutical announced its R&D plan for this year, including some 30 new drug pipelines currently under development, at the 40th J.P. Morgan Healthcare Conference on Jan. 12 (U.S. local time).The drugmaker also revealed its strategy to develop various new drugs, including a COVID-19 vaccine,
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Hanmi Pharm is expected to post consolidated 4Q21 sales of W334.5bn and OP of W32.5bn. We cut our target EV/EBITDA multiple for domestic pharmaceutical peers and lower our estimate for the company’s
A new hurdle has emerged for Hanmi Pharmaceutical in promoting the entry into the 4.5-trillion-won U.S. market of its first bio drug Rolontis. It is a patent infringement suit filed by Sanofi's subsidiary.Analysts say that although the suit is bad news that occurred just before the final approva
The U.S. Food and Drug Administration is expected to conduct due diligence on Hanmi Pharmaceutical's plant in Pyeongtaek sometime in May. The FDA will inspect the production facilities for Hanmi’s neutrophilia drug Rolontis. Originally scheduled for October 2020, the due diligence was postponed
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Although Hanmi Pharm’s consolidated OP for 1Q21 showed a return to the pre-pandemic level, this improvement is mainly due to reduced R&D expenditure. Given reduced GP, top-line growth improvement wil
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. In 2021, Hanmi Pharm should enjoy earnings improvement as the effects of Covid-19 fade. That said, with the firm’s new pipeline having received a CRL from the FDA, we believe that the company needs f
The United States Food and Drug Administration is planning to conduct due diligence on Hanmi Pharmaceutical’s Rolontis manufacturing facilities in May this year. Earlier, it was temporarily postponed due to COVID-19 and the resultant travel restrictions on U.S. government officials.Hanmi Pharmaceuti
The author is an analyst of NH Investment & Securities. He can be reached at william.ku@nhqv.com. -- Ed. With Sanofi confirming its decision to return the rights for Efeglenatide, we expect Hanmi to book unpaid R&D expenses in its accounting, leading to a large-scale operating loss in 3Q20. We maint
Hanmi Pharmaceutical announced on Aug. 18 that it will announce the results of its clinical trial and pre-clinical trial research on LAPSTriple Agonist (HM15211) at the International Liver Congress of the European Association for the Study of the Liver (EASL), which will be held online from Aug.27-2
The author is an analyst of NH Investment & Securities. He can be reached at william.ku@nhqv.com. -- Ed. Sanofi returns Efpeglenatide rights; only Spectrum and Genentech remain as partnersDue to Sanofi’s returning of rights for Efpeglenatide, the drug is excluded from our calculation of Hanmi Pharm’
While the Invossa shock has damaged the credibility of Korea’s biotech industry, Korean biotechnology companies are redoubling efforts to find their way into the overseas market.Industry sources said on June 2 that a total of 37 Korean companies will participate in Bio USA 2019, the world's larg