Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.</li>
<li>Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.</li>
<li>Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.</li>
</ul>


Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.
Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.
Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.


APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

<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>Samsung Biologics launches organoid-based drug screening services to support early-stage drug discovery and development. Daewoong Pharmaceutical signed a five-year KRW74B export agreement for botulinum toxin product with its Thailand partner.</li>
<li>Shionogi’s tender offer for Torii Pharmaceutical has become successful. Simcere stuck outlicensing agreement with NextCure for ADC drug candidate SIM0505 for upfront payment, development, and sales milestones up to $745M.</li>
<li>CSL received FDA approval of Andemry for hereditary angioedema. PharmaEssentia has received marketing approval of Besremi in Argentina. Lotus Pharmaceutical acquires a portfolio of five drugs in Vietnam.</li>
</ul>


Samsung Biologics launches organoid-based drug screening services to support early-stage drug discovery and development. Daewoong Pharmaceutical signed a five-year KRW74B export agreement for botulinum toxin product with its Thailand partner.
Shionogi’s tender offer for Torii Pharmaceutical has become successful. Simcere stuck outlicensing agreement with NextCure for ADC drug candidate SIM0505 for upfront payment, development, and sales milestones up to $745M.
CSL received FDA approval of Andemry for hereditary angioedema. PharmaEssentia has received marketing approval of Besremi in Argentina. Lotus Pharmaceutical acquires a portfolio of five drugs in Vietnam.


APAC Healthcare Weekly (June 22)- Samsung Biologics, Daewoong Pharma, Shionogi, Simcere, CSL

<ul>
<li>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<ul>
<li>Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.</li>
<li>ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.</li>
<li>U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.</li>
</ul>


Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.
ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.
U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.


APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

South Korea

Daewoong Pharmaceutical Co., Ltd. develops various kinds of medical drugs and vitamin supplements.  The Company's medical drugs are used in areas, such as cardiology, dermatology, anti-biotic, and many other medical areas.  Dae Woong's over-the-counter products include smoking deterrents, vitamins, and minerals.

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Daewoong Pharmaceutical Co (069620 KS)

APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Celltrion is acquiring a biopharmaceutical production plant in US. Wuxi Bio starts construction of new facility. CSPC and Jiangsu Hengrui stuck...

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 (June 22)- Samsung Biologics, Daewoong Pharma, Shionogi, Simcere, CSL

Samsung Bio launches new service for early-stage biotechs. Shionogi’s tender offer for Torii becomes successful. Simcere stuck outlicensing deal....

Tina Banerjee

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

Daiichi got EU approval for Enhertu. Kaken Pharma signed inlicensing deal, while ABL stuck outlicensing deal. Sun Pharma's Leqselvi is now free to...

Tina Banerjee

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