Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.</li>
<li>Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.</li>
<li>Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.</li>
</ul>


Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.
Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.
Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.


APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

<ul>
<li>Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.</li>
<li>Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.</li>
<li>Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. </li>
</ul>


Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.
Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.
Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. 


APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

<ul>
<li>Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.</li>
<li>Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.</li>
<li>Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.</li>
</ul>


Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.
Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.
Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.


APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

China

Ascletis Pharma is a fully integrated biotechnology company focused on the research, development, production, marketing, and sale of innovative pharmaceutical products. The company's marketed products include Ritonavir tablets, GANOVO®, and ASCLEVIR® for Hepatitis C, and it has a robust pipeline primarily in metabolic diseases, viral diseases, and oncology. Ascletis Pharma is headquartered in Hangzhou, China, and was founded in 2011.

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Ascletis Pharma (1672 HK)

APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

Akeso’s ivonescimab and Daiichi Sankyo’s Enhertu got additional indications approvals in China. CSPC Pharma’s mpox mRNA vaccine candidate got FDA...

Tina Banerjee

APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Hengrui’s trastuzumab rezetecan got 3rd indication approval in China. CSPC and AstraZeneca form JV for biologics manufacturing facility in China....

Tina Banerjee

APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

Hengrui got NMPA approval for long-acting insulin. FDA approves Otsuka’s new CNS drug. Pharmaessentia announced positive topline result from Phase...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

Sino Bio stuck outlicensing deal with AstraZeneca. Hansoh’s ADC drug candidate met primary endpoint in Phase 3 trial. China will review Astellas’...

Tina Banerjee

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