Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>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

<ul>
<li>CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.</li>
<li>Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.</li>
<li>Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.</li>
</ul>


CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.
Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.
Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.


APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

<ul>
<li>InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.</li>
<li>Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.</li>
<li>Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.</li>
</ul>


InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.
Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.
Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.


APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

<ul>
<li>Jiangsu Hengrui Pharmaceuticals received the NMPA approval for a new indication for dalpiciclib isethionate tablets. InSilico Medicine has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics.</li>
<li>Chugai has filed regulatory application in Japan for sparsentan for the treatment IgA nephropathy. Shionogi has invested in IVF company Dioseve through its corporate venture capital (CVC) initiatives.</li>
<li>Lupin launched Azilsartan Medoxomil tablets in the U.S. for the treatment of hypertension. Dr. Reddy’s Laboratories launched first-to file product Bosutinib tablets, a generic equivalent of Bosulif in the U.S.</li>
</ul>


Jiangsu Hengrui Pharmaceuticals received the NMPA approval for a new indication for dalpiciclib isethionate tablets. InSilico Medicine has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics.
Chugai has filed regulatory application in Japan for sparsentan for the treatment IgA nephropathy. Shionogi has invested in IVF company Dioseve through its corporate venture capital (CVC) initiatives.
Lupin launched Azilsartan Medoxomil tablets in the U.S. for the treatment of hypertension. Dr. Reddy’s Laboratories launched first-to file product Bosutinib tablets, a generic equivalent of Bosulif in the U.S.


APAC Healthcare Weekly (June 21) – Hengrui, InSilico Medicine, Chugai, Shionogi, Lupin, Dr. Reddy’s

Japan

Otsuka Holdings Co Ltd is a pharmaceutical company. The Company manufactures, sells, imports and exports pharmaceuticals, clinical testing, and medical equipment for intractable diseases.

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Otsuka Holdings (4578 JP)

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 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

APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

CSPC, Insilico, and Abiisko inked outlicensing deals with international companies. Nippon Shinyaku inlicenses DMD drug candidate. EMA recommends to...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

Tina Banerjee

APAC Healthcare Weekly (June 21) – Hengrui, InSilico Medicine, Chugai, Shionogi, Lupin, Dr. Reddy’s

Hengrui’s dalpiciclib got label expansion approval in China. Insilico achieved first milestone for co-development collaboration with Hygtia. Chugai...

Tina Banerjee

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