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>Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.</li>
<li>Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.</li>
<li>Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. </li>
</ul>


Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.
Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.
Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. 


APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, 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>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Japan

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

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Nippon Shinyaku (4516 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 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

Hengrui’s camrelizumab got indication expansion approval for cervical cancer. BeOne announced $300M expansion plan for US facility. Samsung...

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 (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Hansoh’s HS-10504 tablets secured BTD in China. Junshi Bio secured 13th indication approval for toripalimab. Daiichi Sanyo’s Enhertu and Datroway...

Tina Banerjee

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