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2025-05-04 04:22
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¡®1+3 will also impact Korea¡¯s patent linkage system'
by
Kim, Jin-Gu
Nov 20, 2023 05:50am
The so-called ¡®1+3 restriction on bioequivalence testing¡¯ system is expected to impact the Drug Approval-Patent Linkage System as well. If applied, the 1+3 system is expected to eradicate the practice of multiple generic companies jointly filing patent challenges and improve the practicality of the first generic exclusivity right (fi
Company
160 billion won Daewoong¡¤Takeda Luphere¡¤Leuplin
by
Nho, Byung Chul
Nov 17, 2023 06:00am
Daewoong Pharmaceutical's Luphere and Takeda Pharmaceutical Leuplin are leading the market in the field of prostate cancer treatment. According to the drug distribution performance data, Luphere and Leuplin ranked 1st and 2nd based on single product sales in the first half of this year, with a performance of 15.4 billion won and 13.9 billio
Company
New drug Camzyos can be prescribed at hospitals
by
Eo, Yun-Ho
Nov 17, 2023 06:00am
The new drug Camzyos for obstructive hypersatic myocardial infarction is entering the general hospital prescription. According to the related industry, Camzyos of BMS Pharmaceutical Korea has passed the Drug Committee (DC) of medical institutions such as SMC and Sinchon Severance Hospital. Camzyos is the first and only treatment that select
Company
GC Biopharma¡¯s Hunterase approved after 11yrs
by
Chon, Seung-Hyun
Nov 17, 2023 05:59am
GC Biopharma¡¯s rare disease treatment ¡®Hunterase¡¯ was granted official marketing authorization 11 years after receiving conditional approval. On the 16th, GC Biopharma announced that it had completed the Phase III trial for its Hunterase on the 14th and changed its license from conditional approval to final marketing authorization.
Company
Will Keytruda¡¯s receive reimb for TNBC in KOR?
by
Eo, Yun-Ho
Nov 17, 2023 05:59am
Whether MSD Korea will be able to make progress in extending reimbursement for its cancer immunotherapy Keytruda for the 13 additional indications it had applied for is receiving attention. According to industry sources, 3 indications of MSD Korea¡¯s PD-1 inhibitor Keytruda (pembrolizumab) are expected to be deliberated by the Health Insu
Company
Large companies more actively engage in patent challenges
by
Kim, Jin-Gu
Nov 17, 2023 05:59am
Pharmaceutical and bio companies with annual sales of more than KRW 300 billion were found to be most actively engaging in patent challenges. As of 2021, pharmaceutical companies with sales exceeding KRW 300 billion applied for an average of 7.7 generic exclusivity approvals per company. The average number of applications for generic exclusiv
Company
GI Innovation registers patent in US for its GI-101/GI-102
by
Nho, Byung Chul
Nov 16, 2023 05:46am
GI Innovation announced on the 15th that it had registered patents for its immune-oncology drug GI-101/GI-102 in combination with various anticancer drugs. The company registered the patent for 101/GI-102 for broad application with global blockbuster anticancer drugs such as PARP inhibitors, CDK4/6 inhibitors, and VEGFR inhibitors, allo
Company
Poteligel can be prescribed at hospitals
by
Eo, Yun-Ho
Nov 15, 2023 05:39am
'Mycobacterial Breed' and 'Poteligel', a treatment for 'siary syndrome', have entered the prescription of a general hospital. According to the relevant industry, Korea Kyowa Kirin's Poteligio (Mogamulijumab) has passed the Drug Committee (DC) of medical institutions such as Seoul Asan Hospital. Potelio passed the Cancer Disease Review
Company
Korean bio companies intent on developing new AD drugs
by
Son, Hyung-Min
Nov 15, 2023 05:39am
Despite downturns, including the return of the rights for JW Pharmaceutical¡¯s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea. Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the
Company
Will the new ADC breast cancer drug Trodelvy be reimb?
by
Eo, Yun-Ho
Nov 15, 2023 05:39am
¡®Trodelvy,¡¯ another new ADC drug for breast cancer, is seeking reimbursement listing in Korea. According to industry sources, Gilead Science Korea has submitted an application for the reimbursement of its triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan-hziy) on July 31, and the agenda is awaiting to be presented
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