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>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>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>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

<ul>
<li>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Japan

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 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 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 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 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

APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

Tina Banerjee

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