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>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>CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.</li>
<li>Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.</li>
<li>SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.</li>
</ul>


CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.
Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.
SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.


APAC Healthcare Weekly (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

<ul>
<li>Innovent Biologics enters global licensing and collaboration agreement with Pfizer for the R&amp;D of 12 promising breakthrough early-stage and de novo cancer medicines. Total value of the deal is $10.5B.</li>
<li>Olympus has decided to acquire Israel-based medical devices manufacturer BioProtect for $270M. GC Biopharma announced that Eli Lilly is acquiring entire stake of its U.S. affiliate Curevo Vaccine for $1.5B.</li>
<li>Daewoong Pharmaceutical received approval for its type 2 diabetes drug Enblo in Mexico. Dong-A ST announced that MetaVia’s obesity drug candidate DA-1726 demonstrated safety and tolerability in Phase 1 trial.</li>
</ul>


Innovent Biologics enters global licensing and collaboration agreement with Pfizer for the R&amp;D of 12 promising breakthrough early-stage and de novo cancer medicines. Total value of the deal is $10.5B.
Olympus has decided to acquire Israel-based medical devices manufacturer BioProtect for $270M. GC Biopharma announced that Eli Lilly is acquiring entire stake of its U.S. affiliate Curevo Vaccine for $1.5B.
Daewoong Pharmaceutical received approval for its type 2 diabetes drug Enblo in Mexico. Dong-A ST announced that MetaVia’s obesity drug candidate DA-1726 demonstrated safety and tolerability in Phase 1 trial.


APAC Healthcare Weekly (May 31) – Innovent Biologics, Junshi Bio, Henlius Bio, Olympus, GC Bio

Japan

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

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Shionogi & Co (4507 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 (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 (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

Innovent submitted NDA for oncology drug. Shionogi got FDA approval for Xocova. Hanmi Pharm signed $1.2B outlicensing deal with Lilly. SK...

Tina Banerjee

APAC Healthcare Weekly (May 31) – Innovent Biologics, Junshi Bio, Henlius Bio, Olympus, GC Bio

Innovent stuck $10.5B outlicensing deal with Pfizer. Olympus will acquire BioProtect. Eli Lilly is acquiring GC Bio’s US affiliate. Dong-A’s...

Tina Banerjee

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