Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.</li>
<li>Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.</li>
<li>Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.</li>
</ul>


CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.
Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.
Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.


APAC Healthcare Weekly (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

<ul>
<li>Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.</li>
<li>FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. </li>
<li>Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.</li>
</ul>


Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.
FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. 
Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.


APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun 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>Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.</li>
<li>WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.</li>
<li>Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.</li>
</ul>


Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.
WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.
Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.


APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

<ul>
<li>RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.</li>
<li>Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.</li>
<li>Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.</li>
</ul>


RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.
Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.
Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.


APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

India

Biocon Ltd., is an integrated biotechnology enterprise with a presence in biopharmaceuticals, enzymes, custom research and clinical research. The Company's pharmaceutical products include statins, immunosuppressants and anti-diabetic drugs. Biocon also manufactures specialty enzymes and new enzyme applications besides providing clinical and custom research services.

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Biocon Ltd (BIOS IN)

APAC Healthcare Weekly (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

CSPC Pharma’s NDA for Anbenitamab injection has been accepted in China. TransThera got trial approval for lead candidate. Samsung Bio signed $1.3B...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

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 (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

Simcere, CSPC, and Sino Bio got approvals for their new drugs in China. Apollo Hospital announced a demerger. Torrent is acquiring controlling...

Tina Banerjee

APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Last week couple of Chinese companies signed outlicensing deals with international players. Innovent got weight loss drug approval in China....

Tina Banerjee

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