Ka la 13 Mphalane, batho ba fetang 180 ba tsoang indastering ea lipatlisiso le nts'etsopele ea ente ea antibody ba ile ba bokana Holong ea Chengdu ea Shanghai Hope Hotel.Matichere a leshome a tsoang indastering ea lipatlisiso le nts'etsopele ea li-antibody-drug le litsi tsa lipatlisiso tsa mahlale le tsona li tlisitse kabo e babatsehang.
Ho qala ka mohopolo le ts'ebeliso ea li-antibodies, Dr. Zhang Aihua o ile a buisana ka ho aroloa le ho bitsoa ha lithethefatsi tsa antibody.Ha a nka CD47 e le mohlala, Ngaka Zhang o ile a hlalosa ka mokhoa oa tšebetso le tšebeliso ea meriana ea litlhare tsa antibody.Hajoale, lipatlisiso le nts'etsopele ea li-antibodies tsa monoclonal li chesa haholo.Ts'ebetsong ea nts'etsopele, re lokela ho khetholla phapang lipakeng tsa nts'etsopele ea li-antibodies tse ncha le taolo ea boleng ba Biosimilar.Ho nts'etsopele ea lithethefatsi tse ncha, lipatlisiso tsa boleng bo lekaneng li lokela ho etsoa ho latela mohopolo oa nts'etsopele ea boleng bo tsoang ho moralo (QbD) le molao-motheo oa ho sireletseha, ho sebetsa hantle le ho ba le boleng bo laolehang.
Dr. Wang Gang, rasaense ea ka sehloohong, o ne a ikarabella bakeng sa ho lumellana le ho hlahloba Setsi sa Tlhahlobo ea Lithethefatsi sa CFDA (CDE).O ile a hlahisa moralo oa Tsamaiso ea Lithethefatsi ea Naha ea Chaena, e leng tsamaiso ea molao ea mekhahlelo e meraro ea melao, melaoana le tataiso ea tekheniki ea Tsamaiso ea Lithethefatsi ea Naha.O boetse a tsebahatsa ditsamaiso tsa ho ngodisa le ho tjhaellwa monwana ha Kopo ya China ya Laesense ya Dihlahiswa tsa Baeloji (BLA) le Kopo e Ntjha ya Dithethefatsi (NDA).O tiisitse hore phetoho ea tsamaiso, molao, le mekhoa ea tumello ea lithethefatsi ea Tsamaiso ea Lithethefatsi ea Naha e tla khothalletsa haholo nts'etsopele ea meriana e mecha Chaena, le ho bapisa tsamaiso ea tlhahlobo ea tsamaiso ea Tsamaiso ea Lijo le Lithethefatsi ea Europe le United States.Qetellong, o ile a bontša maikutlo a hae mabapi le phetoho ea nako e tlang ea tsamaiso ea meriana ea Chaena.Dr. Wang o re tataisitse ho hlahloba taolo e tobileng ea lihlomathiso tsa Molao oa Tsamaiso ea Lithethefatsi oa People's Republic of China le Melawana ea Ngoliso le Tsamaiso ea Lithethefatsi, le phello ea bona e kholo ho indasteri ea R&D ea meriana lilemong tsa morao tjena.
Counttar Rigel e ikemetseng ka ALIT Life Sciences e phethahetse bakeng sa ketsahalo ea setsebi le ea khauta e kang ena.Countstar Altair e etselitsoe indasteri ena ka ho khetheha.Tsamaiso ea eona ea data le ts'ebetso ea taolo e lumellana ka botlalo le FDA 21 CFR Karolo ea 11.E boetse e khona ho fana ka lits'ebeletso tsa netefatso ea 3Q bakeng sa mefuta e fapaneng ea li-granules tsa netefatso.E rarolla ka ho feletseng matšoenyeho a bareki ba indasteri mabapi le taolo ea boleng.
Sebakeng sa kopano, litsebi tse ngata tse tsoang indastering li ile tsa tla ho tla buisana le ho buisana, 'me bohle ba tiisitse ka ntsoe-leng ts'ebetso ea Rigel le ho latela melao ea hae.Countstar e tla tsoelapele ho ts'ehetsa maikutlo a mahlale a matla le a hlokolosi, a ntlafatse khafetsa, le ho thusa indasteri ea antibody ho ba le nts'etsopele e ntle.
Countstar Altair e fana ka ts'ebeletso ea liteko tsa mohlala, 'me e amohela bohle ho etsa kopo!
