Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Jiangsu Hengrui received approval for its innovative drug Retlirafusp alfa Injection in China. Hansoh’s innovative drug Ameile got fifth indication expansion approval in China for NSCLC.</li>
<li>InSilico Medicine entered multi-year R&amp;D collaboration valued at $888M with Servier. Takeda Pharmaceutical filed NDA to the FDA seeking approval of rusfertide for the treatment of polycythemia vera.</li>
<li>Hanmi Pharmaceutical will distribute and sell Teva’s migraine preventive treatment Ajovy in Korea. Dr. Reddy’s Laboratories has launched Hevaxin vaccine for the prevention of Hepatitis E virus infection in India.</li>
</ul>


Jiangsu Hengrui received approval for its innovative drug Retlirafusp alfa Injection in China. Hansoh’s innovative drug Ameile got fifth indication expansion approval in China for NSCLC.
InSilico Medicine entered multi-year R&amp;D collaboration valued at $888M with Servier. Takeda Pharmaceutical filed NDA to the FDA seeking approval of rusfertide for the treatment of polycythemia vera.
Hanmi Pharmaceutical will distribute and sell Teva’s migraine preventive treatment Ajovy in Korea. Dr. Reddy’s Laboratories has launched Hevaxin vaccine for the prevention of Hepatitis E virus infection in India.


APAC Healthcare Weekly (January 11) – Hengrui, Hansoh, InSilico Medicine, Takeda, Hanmi Pharm

<ul>
<li>Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.</li>
<li>Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  </li>
<li>Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.</li>
</ul>


Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.
Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  
Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.


APAC Healthcare Weekly (November 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

<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>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

India

Alkem Laboratories Ltd. is an Indian multinational pharmaceutical company specializing in generics and specialty pharmaceuticals. It manufactures and markets pharmaceutical generics, formulations, and nutraceuticals across India and global markets. The company's product portfolio also includes active pharmaceutical ingredients, branded products, vitamins, minerals, and nutritional products. Alkem Laboratories is headquartered in Mumbai, India, and was founded in 1973.

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Alkem Laboratories (ALKEM IN)

APAC Healthcare Weekly (January 11) – Hengrui, Hansoh, InSilico Medicine, Takeda, Hanmi Pharm

Hegrui got nod for new drug and Hansoh’s Ameile secured additional indication in China. InSilico entered $888M R&D collaboration. Takeda filed for...

Tina Banerjee

APAC Healthcare Weekly (November 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

Celltrion inlicensed two antibody drug candidates in KRW1T deal. Dong-A got domestic approval for Xcopri. Hanmi Pharm will distribute Boehringer...

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 (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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