Samsung Bioepis announced on April 23 that it has received final marketing authorization from the European Commission (EC) for Pyzchiva (project name SB17, ustekinumab), a biosimilar to Stelara. Pyzchiva’s active substance name is ustekinumab.Pyzchiva is the fourth autoimmune disease treatment devel
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Recent ELCC data released by J&J proves that the expanded adverse reactions seen during phase III trials of Mariposa can be managed. With approval expected mid-year, now is the time to pay attention
Samsung Bioepis announced on Feb. 25 that it has obtained a positive opinion for the sale of its biosimilar of Stelara, known as Pyzchiva, from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).The original drug of Pyzchiva developed by Janssen, know
Samsung Biologics has announced a collaboration with LegoChem Biosciences for the development of Antibody-Drug Conjugate (ADC) therapeutics.On Feb.7, Samsung Biologics revealed it had entered into a new Contract Development Organization (CDO) agreement with LegoChem Biosciences (hereinafter referred
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.With MARIPOSA trials displaying a significant improvement in OS, J&J expects the amivantamab+lazertinib combo to become a standard of care. The firm will file for FDA approval in 2023, and strive to
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.The MARIPOSA study has proven the feasibility of lazertinib+amivantamab as a standard first-line treatment. Competing trial FLAURA2 is expected to underperform in terms of OS. In addition, ESMO clini
As the patent for the blockbuster pharmaceutical “Stelara,” which generated more than 23 trillion won (US$17.1 billion) in global sales last year, approaches expiration, domestic biosimilar developers are consistently announcing their clinical trial results. Biosimilars refer to replica drugs develo
The author is an analyst for NH Investment & Securities. He can be reached at kyuha.lee@nhqv.com -- Ed.Phase III MARIPOSA meets primary endpointJanssen announced positive topline results from the pivotal phase III MARIPOSA study evaluating Rybrevant (amivantamab) in combination with lazertinib, a th
The author is an analyst for NH Investment & Securities. He can be reached at seungyeon.han@nhqv.com -- Ed.On Sep 26, the share price of HanAll Biopharma partner Immunovant jumped by over 97% on surprise interim data from the IMVT-1402 phase I trial. Encouraging results were reported in terms of bot
Yuhan Corp. announced that it will collaborate with Cyrus Therapeutics, a biopharmaceutical company with targeted proteolysis development technology, to jointly develop new anti-cancer drugs and candidates.The two companies will conduct basic research on anti-cancer drug development, the joint devel
On Aug. 31, Celltrion announced it has completed the product approval application for its autoimmune disease therapeutic “CT-P43,” a biosimilar of STELARA (ustekinumab), to Australia’s Therapeutic Goods Administration (TGA).Celltrion applied for CT-P43’s product approval in Australia for all indicat
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Yuhan posted 2Q23 consolidated OP of W27.1bn, significantly beating consensus. Earnings should continue to improve on: 1) the likely listing of Lazertinib as a first-line treatment for NSCLC in Korea
The trend of collaborations between domestic and foreign enterprises of various sizes to achieve success in new drug development is on the rise. Such collaborations are viewed within the industry as a potential model for “Korean-style Open Innovation” in the pharmaceutical and biotech sectors.Accord
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.GPM for domestic first-line NSCLC treatment sales is estimated at 62% of GPM for Janssen’s global Lazertinib royalties in 2028. When enrolled in insurance coverage, drug prices tend to fall on a hike
The author is an analysts of NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.At Yuhan, 1Q23 non-consolidated and consolidated OP likely came in at respective W14.6bn (beating consensus) and W13.3bn (missing consensus). We anticipate consolidated earnings improvement after com
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
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed.Maintain BUY; trim target price (KRW72,000→KRW70,000) We trim our TP (KRW72,000→KRW70,000) on Yuhan to reflect changes to 2023 ERP (5.41%), RFR (3.32%) and earnings estimates following the 4Q22 earnings release
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Laser301 data were recently released at the ESMO Asia Congress 2022. Against this backdrop, attention is turning to Janssen’s commercialization strategy for Lazertinib. A competing phase III clinical
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed. Although the global bio sector index continues to be sluggish, we believe it will be important to pay close attention to global clinical trial data for ADC and KRAS inhibitors at 2022 ASCO (Jun 3~7).
The National Academy of Medicine of Korea announced on May 12 that there is a causality between the Pfizer and Moderna COVID-19 vaccines and acute pericarditis.The academy conducted self-controlled case series analysis for a post-inoculation period of six weeks. “When it comes to initial inoculation