Na Machị 10, 2025, Hansoh Pharma kwupụtara na ọgwụ ọhụrụ nke atọ (“NDA”) nke otu Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) ka National Medical Products Administration nke China (“NMPA”) kwadoro maka ọgwụgwọ ndị ọrịa nwere kansa akpa ume nke na-abụghị obere sel (“NSCLC”) nke dị n'ógbè ahụ, nke a na-apụghị ịgbanahụ (“Stage III”) nke na-abụghị obere sel sel (“NSCLC”) nke ọrịa ha na-aga n'ihu mgbe e mechara chemoradiotherapy dabere na platinum nke etuto ahụ nwere epidermal growth factor receptor (“EGFR”) exon 19 deleted ma ọ bụ mgbanwe mgbanwe exon 21 (L858R). Nke a bụ ihe ngosi nke atọ akwadoro maka Ameile kemgbe mmalite azụmahịa ya afọ ise gara aga. N'ihi ya, Ameile aghọwo naanị ọgbọ nke atọ nke EGFR-TKI mepụtara n'ime obodo nke akwadoro maka ọgwụgwọ mmezi na ndị ọrịa nwere ọkwa III nke NSCLC nke a na-apụghị ịgbanahụ mgbe chemotherapytherapy gasịrị.
Nkwenye a dabere na nnyocha POLESTAR (HS-10296-304), nnwale ahụike nke usoro atọ nke enweghị usoro, nke a na-achịkwa site na placebo, iji nyochaa mmetụta nke Ameile dị ka ọgwụgwọ mmezi na ọkwa III nke NSCLC nke a na-apụghị iwepụ mgbe a gbasasịrị chemotherapy. Ọkachamara mmụta bụ Prof. Yu Jinming si Shandong Cancer Hospital duziri ọmụmụ ihe POLESTAR dị ka onye nyocha bụ isi. A họpụtara nsonaazụ ya maka ndepụta "Late Breaking Abstract (LBA)" nke 2024 nke World Conference on Lung Cancer (WCLC) ma gosipụta ya na Symposium nke Onyeisiala nke ogbako ahụ.
Nsonaazụ nnyocha ahụ gosiri na Ameile belatara ihe ize ndụ nke ọrịa site na ihe karịrị 80% yana ndụ dị n'etiti enweghị ọganihu (mPFS) maka ndị ọrịa ejiri Ameile gwọọ bụ ọnwa 30.4 ma e jiri ya tụnyere naanị ọnwa 3.8 maka ndị natara placebo. Na mgbakwunye, uru nke Ameile karịa placebo maka PFS dị otu n'ofe obere ndị niile akọwapụtara, na-egosi profaịlụ uru zuru oke. Ọzọkwa, ọnụego nzaghachi ebumnuche (ORR) na otu ọgwụgwọ Ameile nke BICR nyochachara ruru 57%, yana oge etiti nke nzaghachi (DoR) gbatịkwuru ruo ọnwa 16.59 na etiti ogologo ndụ (OS) erubeghị. Ọnọdụ nke mmerụ ahụ CNS na metastases dị anya dị ala. Nnagide na njikwa zuru oke nke Ameile na ndị ọrịa mgbe ọgwụgwọ kemoradiotherapy dị mma. N'ihe gbasara ihe ndị na-adịghị mma (AEs), ọnọdụ nke pneumonia radieshon nke ọkwa ≥3 bụ 0, yana ọnọdụ nke pneumonia interstitial bụkwa 0.
Banyere Hansoh Pharma
Hansoh Pharma bụ ụlọ ọrụ ọgwụ kachasị elu na Greater China nke ihe ọhụrụ na-akwalite. Ọ na-agba mbọ ịgwọ ọrịa ndị bụ isi n'ihe gbasara ọrịa kansa, mgbochi ọrịa, ọrịa CNS, ọrịa metabolic, yana ọrịa autoimmune, ma na-etinye aka n'ịkwalite ahụike mmadụ site na imepụta ihe ọhụrụ na-aga n'ihu. Ruo ugbu a, Hansoh Pharma ewepụtala ọgwụ ọhụrụ asaa iji mepụta ngwaahịa azụmaahịa dị iche iche. A na-ahọpụta Hansoh Pharma n'ime ụlọ ọrụ ọgwụ 100 kachasị elu n'ụwa niile na ụlọ ọrụ mmepụta ihe atọ kachasị mma na China n'ihe gbasara usoro nyocha na mmepe ọgwụ ruo ọtụtụ afọ, ọ bụkwa ụlọ ọrụ teknụzụ dị elu nke mba na ụlọ ọrụ ngosipụta ihe ọhụrụ teknụzụ mba. E depụtara Hansoh Pharma na Stock Exchange nke Hong Kong na June 2019 (koodu ngwaahịa: 03692.HK). Maka ozi ndị ọzọ, biko gaa na www.hspharm.com.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Email：myimmnet@163.com
Ntụaka
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Oge ozi: Maachị-14-2025