Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.</li>
<li>Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.</li>
<li>HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.</li>
</ul>


Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.
Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.
HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.


APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

<ul>
<li>Fosun Pharma outlicensed XH-S004 to Expedition Therapeutics for $120M upfront and milestone payment. Remegen’s drug candidate met primary endpoint in Phase 3 trial for Sjögren's syndrome in China.</li>
<li>Astellas Pharma announced positive topline results from the Phase 3 trial evaluating Padcev in bladder cancer. Daewoong Pharmaceutical announced positive result for their self-developed semaglutide microneedle patch.</li>
<li>Zydus Lifesciences received FDA approval for chest pain drug Diltiazem Hydrochloride tablets. Lupin has partnered with Sandoz to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.</li>
</ul>


Fosun Pharma outlicensed XH-S004 to Expedition Therapeutics for $120M upfront and milestone payment. Remegen’s drug candidate met primary endpoint in Phase 3 trial for Sjögren's syndrome in China.
Astellas Pharma announced positive topline results from the Phase 3 trial evaluating Padcev in bladder cancer. Daewoong Pharmaceutical announced positive result for their self-developed semaglutide microneedle patch.
Zydus Lifesciences received FDA approval for chest pain drug Diltiazem Hydrochloride tablets. Lupin has partnered with Sandoz to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.


APAC Healthcare Weekly (Aug 17) – Fosun Pharma, Remegen, Astellas, Daewoong Pharma, Zydus, Lupin

<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

HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

<ul>
<li>The Development and Reform Commission of Shenzhen Municipality issued a document about the subsidy for VBP, which is a positive policy and is good for innovation.</li>
<li>The approval of Genuine Biotech’s Azvudine could greatly increase the unpredictability of the approval of domestic innovative drugs, thus greatly increasing the unpredictable risk of domestic innovative drug enterprises.</li>
<li>In terms of internationalization, we summarized what Chinese pharmaceutical companies could do at the current stage. But they are hard to become the mainstream in pharmaceuticals globally in short term.</li>
</ul>


The Development and Reform Commission of Shenzhen Municipality issued a document about the subsidy for VBP, which is a positive policy and is good for innovation.
The approval of Genuine Biotech’s Azvudine could greatly increase the unpredictability of the approval of domestic innovative drugs, thus greatly increasing the unpredictable risk of domestic innovative drug enterprises.
In terms of internationalization, we summarized what Chinese pharmaceutical companies could do at the current stage. But they are hard to become the mainstream in pharmaceuticals globally in short term.


China Healthcare Weekly (July.29)-Subsidy for VBP, Unpredictable NMPA, Ways for Internationalization

<ul>
<li>The MPP announced that it has signed agreements with 27 generic manufacturing companies including several Chinese companies for the manufacturing of molnupiravir and supply in 105 low- and-middle-income countries.</li>
<li>The profit margin would be limited because of its public benefit purpose. Therefore, it may not be able to bring huge incremental performance to the relevant domestic pharmaceutical companies.</li>
<li>The future risks and concerns on Merck's molnupiravir should also not be neglected. So, investors are advised to view this agreement with MPP rationally.</li>
</ul>


The MPP announced that it has signed agreements with 27 generic manufacturing companies including several Chinese companies for the manufacturing of molnupiravir and supply in 105 low- and-middle-income countries.
The profit margin would be limited because of its public benefit purpose. Therefore, it may not be able to bring huge incremental performance to the relevant domestic pharmaceutical companies.
The future risks and concerns on Merck's molnupiravir should also not be neglected. So, investors are advised to view this agreement with MPP rationally.


Would the Cheap Versions of Oral COVID-19 Antiviral Bring New Opportunities for Chinese Companies?

China

Kintor Pharmaceutical is a clinical-stage biotechnology company focused on developing innovative small molecule and biological therapeutics for dermatology and oncology, including treatments for androgenetic alopecia, acne vulgaris, and various cancers. The company also develops high-end cosmetics. Kintor Pharmaceutical was founded in 2009 and is headquartered in Suzhou, People's Republic of China.

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Kintor Pharmaceutical (9939 HK)

APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

Couple of Chinese companies got clinical trials approvals for their respective drug candidates. Astellas’ Phase 3 trial failed to meet primary...

Tina Banerjee

APAC Healthcare Weekly (Aug 17) – Fosun Pharma, Remegen, Astellas, Daewoong Pharma, Zydus, Lupin

Astellas, Remegen, and Daewoong Pharma announced positive trial results for their respective drug candidates. Fosun Pharma stuck outlicensing deal....

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

China Healthcare Weekly (July.29)-Subsidy for VBP, Unpredictable NMPA, Ways for Internationalization

The policy about subsidy for VBP is a positive sign for innovation. NMPA is unpredictable, increasing the uncertainty of drug approval. Here's what...

Xinyao (Criss) Wang

Would the Cheap Versions of Oral COVID-19 Antiviral Bring New Opportunities for Chinese Companies?

Some Chinese companies are allowed to make cheap versions of Merck’s molnupiravir based on the MPP agreement.We analyzed the impact and outlook,...

Xinyao (Criss) Wang

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