Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.</li>
<li>Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.</li>
<li>Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. </li>
</ul>


Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.
Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.
Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. 


APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

<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>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

<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>Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.</li>
<li>Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.</li>
</ul>


Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.
Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.
Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.


APAC Healthcare Weekly (Aug 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

Taiwan

Oneness Biotech Co Ltd develops botanical new drugs and several biological-active new chemical entities that are purified and molecularly modified from these botanical sources.

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Oneness Biotech (4743 TT)

APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Hengrui’s trastuzumab rezetecan got 3rd indication approval in China. CSPC and AstraZeneca form JV for biologics manufacturing facility in China....

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 (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

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 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

Terumo announced new acquisition. Eisai got FDA approval for Leqembi subcutaneous maintenance dosing. Chugai’s oral GLP-1 drug showed positive P3...

Tina Banerjee

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