I-NMPA yaseTshayina Ivuma Isalathisi Esitsha seBireociclib: Ithemba Elitsha Lokuqala Lomhlaza Webele Ophambili we-HR+/HER2

Kutshanje, i-China National Medical Products Administration (NMPA) ivumile uphawu olutsha lweBireociclib, iyeza elitsha leKlasi 1 elenziwe ngokuzimeleyo yiXuanzhu Biopharmaceutical. Olu phawu lutsha lusetyenziswa kunye ne-aromatase inhibitor njengonyango lokuqala lwe-endocrine kwizigulane ezine-HR+/HER2- advanced breast cancer. Olu vunyiweyo lubonisa iBireociclib njengeyeza lokuqala nelokuphela kwalo kudidi lwayo eTshayina ukugubungela ikhosi epheleleyo yonyango lwe-HR+/HER2- advanced breast cancer—kuquka unyango lomgca wokuqala, lomgca wesibini, kunye nonyango lomgca olandelayo—olubonelela ngokhetho olutsha lonyango kwizigulane kwihlabathi liphela.

Ukuba wena okanye abo ubathandayo nifuna iindlela ezingcono zonyango lomhlaza webele, nceda unxibelelane neSebe leHlabathi leBeijing South Region Oncology Hospital:

 

- Ifowuni: 400-880-3716

- WeChat: 17801183037

- Email ①: 100085_010@163.com

- Email ②: myimmnet@163.com

 

 

**Ukusuka kuMgca Wesibini ukuya kuMgca Wokuqala: Ulwahlulo "lweKhosi Epheleleyo" lweBireociclib**

 

I-Bireociclib yi-CDK2/4/6 inhibitor entsha. Yayivunyiwe ngaphambili ukuba isetyenziswe kunye ne-fulvestrant yomhlaza webele oqhubele phambili emva konyango lwe-endocrine, kunye nonyango olulodwa kwizigulana ezinesifo sokungavumi. Ukuvunywa kwale ngxelo intsha kuqhubela phambili ukusetyenziswa kwayo kunyango lwe-endocrine lomgca wokuqala, ngokwenene kufikelela kukhuseleko olupheleleyo ukusuka kunyango lokuqala ukuya kunyango lokuhlangula lomgca olandelayo.

 

Olu vunywa lusekelwe kwiziphumo zohlalutyo lwexeshana zophando lwe-BRIGHT-3. Olu phononongo lubonise ukuba i-median progression-free survival (PFS) yeqela le-Bireociclib kunye ne-AI ayikafikelelwa, nto leyo ebonisa ukusebenza okuhlala ixesha elide; xa kuthelekiswa, i-PFS yeqela lolawulo yayiyiinyanga ezili-18.4. Okukhuthazayo nangakumbi kukuba, izinga le-PFS leminyaka emi-2 kwiqela le-Bireociclib lidlule kwi-60%, kwaye izinga lokuphendula elijolise ngqo (ORR) lifikelele kwi-63.5%, linyuke laya kwi-67.6% kwizigulane ezinezilonda ezinokulinganiswa. Ezi datha zibonisa ukuba i-Bireociclib okwangoku ibonisa ukusebenza okuphezulu phakathi kwamayeza afanayo.

 

**Uyilo Oluntsonkothileyo: Ukusebenza kakuhle kunye noKhuseleko olujolise kwiinjongo ezininzi**

 

Ukwahluka kweBireociclib kukwindlela yayo yokusebenza ngokubambisana ejolise kwiinjongo ezininzi. Njengesithinteli esitsha seCDK2/4/6, ayigcini nje ngokuthintela ngamandla iCDK4 kunye neCDK6 kodwa ikwathintela ngaxeshanye iCDK2 kunye neCDK9.

 

- **Ukulibazisa Ukuxhathisa Amayeza:** Ukusebenza kwe-CDK2 yenye yeendlela eziphambili zokuxhathisa ii-CDK4/6 inhibitors. Ngokuthintela i-CDK2 ngaxeshanye, iBireociclib inokuthintela ngokupheleleyo iindlela zokwanda kweeseli zethumba, ngaloo ndlela ilibazise ukuqala kokuxhathisa amachiza kumthombo.

- **Ubuthi obuphantsi:** Ubuthi begazi obufana ne-neutropenia yebanga lesi-3/4, edla ngokubonwa nge-CDK4/6 inhibitors yendabuko, buncitshiswa kakhulu ngonyango lweBireociclib. Oku kuthetha ukuba izigulana zinokufikelela kunyamezelo olungcono lonyango, zinciphise ukuphazamiseka konyango ngenxa yeziphumo ebezingalindelekanga, ngaloo ndlela ziqinisekisa ukuqhubeka kokusebenza kakuhle.

 

**Idatha Iqinisekisa Amandla: Impumelelo Epheleleyo Yothotho Lophononongo Olukhanyayo**

 

Ukusebenza kakuhle kweBireociclib akuyonto ingaqhelekanga kodwa yakhelwe phezu kwesiseko esiqinileyo sothotho lwezifundo zeBRIGHT:

 

- **Uphononongo oluQINILEYO-2 (Unyango loLuhlu lweSibini):** I-Bireociclib edityaniswe ne-fulvestrant ifumene i-PFS ephakathi yeenyanga ezili-17.5. Kwiintengiselwano ezingangqamananga, le datha yeyona ibalaseleyo kudidi.

- **Uphononongo oluQINILEYO-1 (iMonotherapy yoMgca oLater-Line):** Kwizigulane ezinyangwe kakhulu, eziphucuke kakhulu, iBireociclib monotherapy ibangele i-PFS ephakathi yeenyanga ezili-11 kunye nokusinda okuphakathi (OS) kweenyanga ezingama-29. Le ikwayindawo yedatha ebalaseleyo kwihlabathi liphela, ebonisa ukusebenza kwayo okunamandla kubantu abanengxaki enkulu.

 

**Kutheni Ufanele Ukhethe iSebe leHlabathi leSibhedlele se-Oncology saseBeijing South Region?**

 

ISebe leMicimbi yeHlabathi leSibhedlele se-Oncology saseBeijing South Region lizinikele ekudibaniseni uphuhliso lwehlabathi oluphambili lwamayeza kunye nezixhobo zonyango zaseTshayina eziphezulu. Njengeyeza elitsha eliphuhliswe eTshayina, ukuvunywa kweBireociclib akuncedi nje kuphela izigulana zasekhaya kodwa kunika nethemba elitsha kwizigulana zamazwe ngamazwe. ISebe lethu leMicimbi yeHlabathi libonelela izigulana zaphesheya kwezilwandle ngezi zinto zilandelayo:

 

1. **Ukubonisana ngeengcali ezahlukeneyo:** Uvavanyo lweemeko zonyango kunye nophuhliso lwezicwangciso ezenzelwe wena liqela leengcali eziphambili kwicandelo lomhlaza webele.

2. **Ukufikelela kwiMithi eNtsha:** Ukufikelela kwangethuba kwimithi emitsha echasene nomhlaza evunyiweyo eTshayina, kuquka neBireociclib.

3. **Inkonzo Epheleleyo:** Inkxaso yezonyango enikezelwa kanye, ukusuka kwingcebiso yokuqala kunye nokuphunyezwa kwesicwangciso sonyango ukuya kulandelelwano lwexesha elide.

4. **Uncedo loLwimi noThutho:** Uguqulelo lwezonyango oluyingcali kunye nokufikelela okuzinikeleyo kwizigulane zamazwe ngamazwe ukujongana neengxaki zezothutho.

**Qhagamshelana Nathi Ngoku**

Ukuba wena okanye amalungu osapho lwakho nilwa nomhlaza webele oqhubele phambili we-HR+/HER2 kwaye ninqwenela ukufunda ukuba iBireociclib ingaba lolona hlobo lufanelekileyo lonyango, nceda unxibelelane neSebe leHlabathi leSibhedlele se-Oncology saseBeijing South Region ngoko nangoko. Iqela lethu leengcali liza kukunika iingcebiso zonyango ezineenkcukacha kunye noncedo lokufuna unyango eTshayina.

- ��� Ifowuni: 400-880-3716

- ��� WeChat: 17801183037

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

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Ixesha leposi: Matshi-06-2026