Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.</li>
<li>Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.</li>
<li>Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.</li>
</ul>


CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.
Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.
Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.


APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

<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>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>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>CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.</li>
<li>Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.</li>
<li>Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.</li>
</ul>


CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.
Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.
Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.


APAC Healthcare Weekly (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

South Korea

LegoChem Biosciences, Inc. (LCB) is a researched-based biotechnology company that discovers, develops, and commercializs of medicines.  The Company utilizes chemistry to make biologics more targeted and potent for patients with diseases of highly unmet medical needs.  The Company focuses on therapy within antibiotics, anti-coagulants, oncology, antibody and protein-drug conjugate.

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Legochem Biosciences (141080 KS)

APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

CSPC and Akeso announced positive results from their respective Phase 3 trials for cancer drug candidates. Takeda got FDA approval for blood cancer...

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 (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 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 (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

CStone’s sugemalimab got label expansion in UK. HBM Holdings entered exclusive license agreement with Solstice Oncology. Astellas Pharma and Vir...

Tina Banerjee

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