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BI rare skin disease drug San Lizo China approved; China Pharmaceutical will be responsible for the import and distribution of Paxlovid in Chinese mainland

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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Pharmacis Selection

Boehringer Ingelheim rare dermatology drug IL-36R monoclonal antibody San Ligzo China approved

Boehringer Ingelheim today announced that its application for the marketing of its innovative drug for rare skin diseases, San Lizo (pesolimab injection), has been approved by the State Food and Drug Administration for the treatment of generalized pustular psoriasis (GPP) in
adults.
It is worth mentioning that San Lizhuo has been qualified for breakthrough therapy drug recognition and priority review and approval by the State Food and Drug Administration, which is only three months
away from the approval time in the United States.
San Richo is a novel humanized selective IgG1 monoclonal antibody that blocks the activation
of the interleukin-36 receptor (IL-36R).
The IL-36 pathway is a signaling pathway within the immune system that has been shown to be involved in
the pathogenesis of various autoinflammatory diseases such as GPP.
International multicenter, double-blind, randomized controlled phase II Effisayil 1 Studies showed that 54.
3% of patients achieved no visible pustules on the skin after 1 week of treatment with San Ligore; In 42.
9% of patients, 1 week of treatment with San Lead, clearance or near-clearance of skin symptoms was achieved with a good safety profile, with common adverse events including fever and mild to moderate infection
.

Henlius GARP Monoclonal Antibody HLX60 Initiates Phase I Clinical Trials in Australia

Shanghai Henlius Biotechnology Co.
, Ltd.
announced that the first patient administered
in Australia in the phase I clinical study of HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) combined with Hans-like (serplulimab injection) for the treatment of advanced or metastatic solid tumors 。 Henlius' innovative anti-PD-1 monoclonal antibody was approved by the NMPA in March 2022 for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) solid tumors that have failed standard therapy, and is planned for the treatment of a variety of solid tumors, and two more applications for lung cancer indications have been accepted
.
Henlius is also developing 11 combination therapies with Hans-like at its core, and conducting simultaneous clinical trials
in multiple countries and regions around the world.
HLX60 is Henlius' innovative anti-glycoprotein A repeat dominant protein (GARP) monoclonal antibody for the treatment
of solid tumors and lymphomas.

Enterprise dynamics

Genting Xinyao's mRNA rabies vaccine project with Providence reached milestone, triggering the closing of shares

On December 15, Genting Xinyao announced that its newly developed mRNA rabies vaccine program has achieved positive results in preclinical studies such as immunogenicity, and has reached its preclinical proof-of-concept milestone
.
The new vaccine candidate is Genting Xinyao and partner Providence Therapeutics Holdings Inc.
was developed using a clinically proven mRNA technology platform for prophylaxis following rabies virus exposure
.
Previously, Genting Xinyao and Providence reached a license
agreement in September 2021.
Genting Xinyao received multinational rights to Providence's mRNA vaccine and two other global rights for preventive or therapeutic products; This milestone rabies vaccine project is included
.
The two parties have a peer-to-peer (50/50) global interest
in the development and commercialization of this novel mRNA rabies vaccine.
Genting New Yao is required to issue 3,492,365 shares to Providence upon the closing of the third tranche of milestones as partial consideration under the partnership and licensing agreement
.

China National Pharmaceutical will be responsible for the import and distribution of Pfizer's new crown oral drug Paxlovid in Chinese mainland

On December 15, China National Health Industry Co.
, Ltd.
announced the signing of an agreement
with Pfizer.
Sinopharm will be responsible for the import and distribution of Pfizer's novel coronavirus treatment Paxlovid (nematevir/ritonavir tablets) in the Chinese mainland market during the agreement period (December 14, 2022 to November 30, 2023
).
On March 9, 2022, the two parties reached an agreement that China Pharmaceutical would be responsible for Paxlovid's commercial operation
in the Chinese mainland market in 2022.
Paxlovid is an oral small molecule novel coronavirus treatment for adults with mild to moderate novel coronavirus pneumonia with risk factors for progression to severe disease, such as the elderly (over 60 years old) or patients
with one or more risk factors (such as chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease).
On February 11, 2022, Paxlovid was conditionally approved by the China National Food and Drug Administration (NMPA) for emergency listing with a purchase price of 2,300 yuan per box and has been included in medical insurance
.

Instrument news

Syntruda Medical NEO-Skater China was approved for marketing

On December 15, Syntruda Medical Technology Holdings Co.
, Ltd.
announced that its intracranial PTA balloon NEO-Skater, which improves intracranial blood flow perfusion in atherosclerotic intracranial vessels, has been approved
by the State Food and Drug Administration.
NEO-Skater has improved the lubricating coating of the catheter platform and balloon to ensure smooth passage
in a tortuous and narrow vascular environment.

Guichuang Tongqiao recyclable vena cava filter was approved for marketing by the State Food and Drug Administration

Guichuang Tongqiao Medical Technology Co.
, Ltd.
issued an announcement that the company's self-developed recyclable vena cava filter - ZYLOX Octoplus has received marketing approval from the State Food and Drug Administration for the prevention of pulmonary embolism (PE),
mainly caused by peripheral deep vein thrombosis (DVT).
The number of DVT cases in China is estimated to increase from 15 million in 2019 to 33 million in 2030, with a compound annual growth rate of 7.
3%.

In China, interventional procedures, including inferior vena cava filter (IVCF) therapy, have become the first choice for the
treatment of lower extremity DVT.
The number of IVCF interventional procedures in China is estimated to increase from 85,700 in 2019 to 673,700 in 2030, with a compound annual growth rate of 20.
6%.

ZYLOX Octoplus has an innovative structural design with excellent vena cava immediate adhesion performance and excellent autonomous balancing ability, more precise filter release, and more efficient
long-term interception of blood clots.
At the same time ZYLOX Octoplus vena cava filters reduce the risk of pulmonary embolism, have a longer window of thrombolytic therapy, and improve the cure rate
of deep vein thrombosis.

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