Ua ʻae ʻo NMPA o Kina i kahi hōʻailona hou no Bireociclib: He Manaʻolana Laina Mua Hou no ka HR+/HER2- Ka maʻi ʻaʻai umauma holomua

I kēia mau lā aku nei, ua ʻāpono ka China National Medical Products Administration (NMPA) i kahi hōʻailona hou no Bireociclib, kahi lāʻau lapaʻau hou o ka Papa 1 i hoʻomohala kūʻokoʻa ʻia e Xuanzhu Biopharmaceutical. ʻO ka hōʻailona hou no ka hoʻohana ʻana me kahi mea hoʻopaʻa aromatase ma ke ʻano he lāʻau lapaʻau endocrine mua no nā poʻe maʻi me ka maʻi ʻaʻai umauma holomua HR+/HER2. Hōʻailona kēia ʻāpono iā Bireociclib ʻo ia ka lāʻau lapaʻau mua a hoʻokahi wale nō i kāna papa ma Kina e uhi i ke kaʻina hana piha no ka maʻi ʻaʻai umauma holomua HR+/HER2—me nā lāʻau lapaʻau laina mua, laina lua, a me nā laina hope—e hāʻawi ana i kahi koho lapaʻau hou no nā poʻe maʻi ma ka honua holoʻokoʻa.

Inā ʻoe a i ʻole kāu poʻe aloha e ʻimi nei i nā koho lapaʻau ʻoi aku ka maikaʻi no ka maʻi ʻaʻai umauma, e ʻoluʻolu e hoʻokaʻaʻike aku i ka International Department of Beijing South Region Oncology Hospital:

 

- Kelepona: 400-880-3716

- WeChat: 17801183037

- Email ①: 100085_010@163.com

- Email ②: myimmnet@163.com

 

 

**Mai ka Laina ʻElua a i ka Laina Mua: Ka Holomua “Papa Piha” o Bireociclib**

 

He mea hoʻopaʻa CDK2/4/6 hou ʻo Bireociclib. Ua ʻae mua ʻia no ka hoʻohana ʻana me ka fulvestrant no ka maʻi ʻaʻai umauma holomua i holomua ma hope o ka lāʻau endocrine, a me ka monotherapy no nā maʻi me ka maʻi refractory. ʻO ka ʻae ʻia o kēia hōʻailona hou e hoʻolaha i kona hoʻohana ʻana i ka lāʻau endocrine laina mua, e hoʻokō maoli ana i ka uhi piha mai ka lāʻau mua a i ka lāʻau hoʻopakele laina hope.

 

Hoʻokumu ʻia kēia ʻae ʻia ma nā hopena loiloi waena o ke aʻo ʻana ʻo BRIGHT-3. Ua hōʻike ka haʻawina ʻaʻole i hiki i ka median progression-free survival (PFS) no ka hui Bireociclib me AI, e hōʻike ana i kahi hopena paʻa loa; i ka hoʻohālikelike ʻana, ʻo ka PFS no ka hui kaohi he 18.4 mau mahina. ʻOi aku ka hoʻoikaika, ʻoi aku ka nui o ka PFS 2 makahiki ma ka hui Bireociclib ma mua o 60%, a ua hōʻea ka objective response rate (ORR) i 63.5%, e piʻi ana i 67.6% i nā maʻi me nā ʻeha hiki ke ana ʻia. Hōʻike kēia mau ʻikepili e hōʻike nei ʻo Bireociclib i kēia manawa i ka hopena maikaʻi loa ma waena o nā lāʻau like.

 

**Hoʻolālā ʻoi aku ka ʻoi aku ka akamai: Multi-Target Synergy Balancing Efficacy a me ka palekana**

 

ʻO ke ʻano kū hoʻokahi o Bireociclib aia i loko o kāna ʻano hana synergistic multi-target. Ma ke ʻano he mea hoʻopaʻa CDK2/4/6 hou, ʻaʻole ia e kāohi wale i ka CDK4 a me CDK6 akā ke kāohi pū nei hoʻi i ka CDK2 a me CDK9 i ka manawa like.

 

- **Ke Hoʻopaneʻe nei i ke Kūʻē ʻana i ka Lāʻau Lapaʻau:** ʻO ka hoʻoulu ʻana o CDK2 kekahi o nā ʻano hana koʻikoʻi o ke kūʻē ʻana i nā mea hoʻopaʻa CDK4/6. Ma ka pale ʻana i ka CDK2 i ka manawa like, hiki iā Bireociclib ke ālai pono i nā ala hoʻonui o nā pūnaewele tumor, a laila e hoʻopaneʻe ana i ka hoʻomaka ʻana o ke kūʻē ʻana i ka lāʻau mai ke kumu.

- **ʻOi aku ka haʻahaʻa o ka ʻawahia:** Ua hoʻemi nui ʻia nā ʻawahia hematological e like me ka neutropenia papa 3/4, i ʻike pinepine ʻia me nā mea hoʻopaʻa CDK4/6 kuʻuna, me ka mālama ʻana iā Bireociclib. ʻO ke ʻano kēia, hiki i nā mea maʻi ke hoʻokō i ka hoʻomanawanui lapaʻau maikaʻi aʻe, e hōʻemi ana i nā hoʻopau ʻana o ka lapaʻau ma muli o nā hopena ʻaoʻao, a pēlā e hōʻoia ai i ka hoʻomau ʻana o ka pono.

 

**Hōʻoia ka ʻIkepili i ka Ikaika: Holomua Holoʻokoʻa o ka Moʻo Haʻawina BRIGHT**

 

ʻAʻole ka hana maikaʻi loa o Bireociclib he hihia kaʻawale akā ua kūkulu ʻia ma luna o kahi kahua paʻa o ka moʻo haʻawina BRIGHT:

 

- **Haʻawina BRIGHT-2 (Lapaʻau Laina ʻElua):** Ua loaʻa iā Bireociclib i hui pū ʻia me ka fulvestrant kahi PFS waena o 17.5 mau mahina. Ma nā hoʻohālikelike ʻole-poʻo-a-poʻo, ʻo kēia ʻikepili ka mea maikaʻi loa ma ka papa.

- **Haʻawina BRIGHT-1 (Later-Line Monotherapy):** No nā poʻe maʻi i mālama mua ʻia a paʻakikī loa i ka hoʻōla ʻana, ua hopena ka Bireociclib monotherapy i kahi PFS waena o 11 mau mahina a me ka awelika o ke ola holoʻokoʻa (OS) o 29 mau mahina. He ʻikepili honua maikaʻi loa kēia, e hōʻike ana i kona pono ikaika i nā heluna maʻi paʻakikī loa.

 

**No ke aha e koho ai i ka Halemai Oncology o ka ʻOihana Honua o Beijing South Region?**

 

Ua hoʻolaʻa ʻia ka ʻOihana Honua o ka Halemai Oncology Hema o Beijing no ka hoʻopili ʻana i ka hana hou o nā lāʻau lapaʻau honua me nā kumuwaiwai lapaʻau Kina kiʻekiʻe. Ma ke ʻano he lāʻau lapaʻau hou i hoʻomohala ʻia ma Kina, ʻo ka ʻae ʻia ʻana o Bireociclib ʻaʻole wale nō ka pōmaikaʻi o nā maʻi kūloko akā hāʻawi pū i ka manaʻolana hou no nā maʻi o ka honua. Hāʻawi kā mākou ʻOihana Honua i nā maʻi o nā ʻāina ʻē me:

 

1. **Kūkākūkā Multidisciplinary:** Loiloi ʻana i nā kūlana olakino a me ka hoʻomohala ʻana i nā hoʻolālā pilikino e kahi hui o nā loea alakaʻi i ke kahua maʻi ʻaʻai umauma.

2. **Ke komo ʻana i nā lāʻau lapaʻau hou:** Loaʻa i ka manawa kūpono nā lāʻau lapaʻau anticancer hou loa i ʻae ʻia e Kina, me Bireociclib.

3. **Lawelawe Hana Piha:** Kākoʻo lapaʻau hoʻokahi, mai ke kūkākūkā mua ʻana a me ka hoʻokō ʻana i ka hoʻolālā lapaʻau a hiki i ka hahai ʻana i ka wā lōʻihi.

4. **Kōkua ʻŌlelo a me ka Halihali:** Unuhi lapaʻau ʻoihana a me ke komo kūikawā no nā poʻe maʻi o ka honua e hoʻoponopono i nā pilikia logistical.

**E leka uila mai iā mākou i kēia manawa**

Inā ʻoe a i ʻole kou ʻohana e hakakā nei me ka maʻi ʻaʻai umauma holomua HR+/HER2 a makemake ʻoe e ʻike inā he koho lapaʻau kūpono paha ʻo Bireociclib, e ʻoluʻolu e kelepona koke aku i ka International Department of Beijing South Region Oncology Hospital. E hāʻawi kā mākou hui loea iā ʻoe i nā kūkākūkā lapaʻau kikoʻī a me ke kōkua no ka ʻimi ʻana i ka mālama olakino ma Kina.

- �� Kelepona: 400-880-3716

- �� WeChat: 17801183037

- ��� Email: 100085_010@163.com or myimmnet@163.com

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Ka manawa hoʻouna: Malaki-06-2026