Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.</li>
<li>Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.</li>
<li>Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.</li>
</ul>


Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.
Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.
Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.


APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

<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>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>SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.</li>
<li>Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.</li>
<li>Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.</li>
</ul>


SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.
Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.
Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.


APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

<ul>
<li>Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.</li>
<li>Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  </li>
<li>The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.</li>
</ul>


Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.
Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  
The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.


APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Japan

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

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Nippon Shinyaku (4516 JP)

APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

Simcere stuck license pact with Vigonvita. Kelun Bio inked partnership with Crescent Biopharma. Samsung Biologics is acquiring land for third...

Tina Banerjee

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 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 (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

SillaJen got FDA nod for clinical trial indication expansion. FDA approves Akeso’s first drug. Innovent’s cancer drug was approved in China....

Tina Banerjee

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

Tina Banerjee

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