Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.</li>
<li>Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.</li>
<li>Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.</li>
</ul>


Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.
Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.
Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.


APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

<ul>
<li>WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.</li>
<li>Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.</li>
<li>Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.</li>
</ul>


WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.
Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.
Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.


APAC Healthcare Weekly (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

<ul>
<li>Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.</li>
<li>WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.</li>
<li>Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.</li>
</ul>


Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.
WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.
Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.


APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

<ul>
<li>Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.</li>
<li>FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.</li>
<li>Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.</li>
</ul>


Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.
FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.
Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.


APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

<ul>
<li>3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.</li>
<li>CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.</li>
<li>Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.</li>
</ul>


3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.
CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.
Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.


APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

South Korea

Hanmi Pharm. Company Ltd. produces pharmaceutical products, including antibiotics, vitamins, and intestinal tonics.  The Company also provides beverages and processes soft capsules for other pharmaceutical firms.

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Hanmi Pharm (128940 KS)

APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

Fosun Pharma and Astellas got new drug approvals. Chugai and SK Biopharma announced positive Phase 3 trial result. Alteogen’s technology powered...

Tina Banerjee

APAC Healthcare Weekly (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

Wuxi Bio got EMA nod for Ireland manufacturing facility. Daiichi Sankyo got breakthrough therapy designation for its drug candidate in US. CSL...

Tina Banerjee

APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

Tina Banerjee

APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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