No Result
View All Result
SUBMIT YOUR ARTICLES
  • Login
Thursday, June 12, 2025
TheAdviserMagazine.com
  • Home
  • Financial Planning
    • Financial Planning
    • Personal Finance
  • Market Research
    • Business
    • Investing
    • Money
    • Economy
    • Markets
    • Stocks
    • Trading
  • 401k Plans
  • College
  • IRS & Taxes
  • Estate Plans
  • Social Security
  • Medicare
  • Legal
  • Home
  • Financial Planning
    • Financial Planning
    • Personal Finance
  • Market Research
    • Business
    • Investing
    • Money
    • Economy
    • Markets
    • Stocks
    • Trading
  • 401k Plans
  • College
  • IRS & Taxes
  • Estate Plans
  • Social Security
  • Medicare
  • Legal
No Result
View All Result
TheAdviserMagazine.com
No Result
View All Result
Home Market Research Business

LakeShore Biopharma Initiates Biologics License Application of PIKA Rabies Vaccine to the Drug Regulatory Authority of Pakistan By Investing.com

by TheAdviserMagazine
7 months ago
in Business
Reading Time: 4 mins read
A A
LakeShore Biopharma Initiates Biologics License Application of PIKA Rabies Vaccine to the Drug Regulatory Authority of Pakistan By Investing.com
Share on FacebookShare on TwitterShare on LInkedIn



GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) — LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (LakeShore Biopharma or the Company), a global leader in the discovery, development, manufacturing, and delivery of next-generation vaccines and therapeutic biologics for infectious diseases and cancer, today announced the initiation of its Biologics License Application (BLA) submission to the Drug Regulatory Authority of Pakistan (DRAP) for the  conditional approval of its PIKA rabies vaccine for post-exposure prophylaxis. This submission is based on the results that met the primary endpoints of the vaccine’s global pivotal trial and demonstrated the vaccine’s potential to achieve accelerated protection and meet the WHO’s goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

Rabies has an almost 100% fatality rate once clinical symptoms appear, leading to approximately 59,000 deaths annually in over 150 countries. More than 95% of rabies fatalities result from bites by infected dogs, with 40% of victims being children under 15. While rabies is typically fatal without treatment, timely post-exposure prophylaxis can effectively prevent death.

Pakistan ranks among the top five countries in the world for human rabies prevalence, with over 1.5 million reported dog bites and an estimated 2,000“5,000 human deaths annually. The true impact is likely underestimated due to underreporting. Rabies vaccines remain costly and are often inaccessible in public health sectors. LakeShore Biopharma’s PIKA rabies vaccine could play a pivotal role in addressing this urgently unmet medical need.

The PIKA Rabies Vaccine, which utilizes LakeShore Biopharma’s proprietary PIKA adjuvant technology based on Toll-like receptor 3 immunological pathway, is designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines. It was granted orphan drug designation by the  US FDA  for prevention of rabies virus infection including post-exposure prophylaxis (PEP) for rabies.

The pivotal registration Phase 3 Trial was a randomized, comparator-controlled, double-blind, multicenter trial which includes 4,500 participants from  the Philippines  and  Pakistan. It is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule, versus a globally marketed comparator following the standard 28-day regimen.  The primary immunogenicity endpoints of the study were geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants. This accelerated and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.

Dr.  Zenaida Mojares, Chief Medical (TASE:) Officer of LakeShore Biopharma, commented, Our existing rabies vaccine, YSJA, has protected tens of millions of patients in China from this deadly disease. We are committed to advancing next-generation PIKA adjuvanted rabies vaccines to enhance patient protection. The promising results from our pivotal trial validate the potential of PIKA technology to generate a stronger and faster immune response. We remain committed to working closely with drug regulatory agencies in various countries regarding the product registration and marketing application. We eagerly anticipate the early approval of this innovative therapy for the benefit of patients worldwide.

About LakeShore Biopharma

LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA ®  immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.lakeshorebio.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma’s ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as estimate, plan, project, potential, forecast, intend, will, expect, anticipate, believe, goal, seek, target or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma’s management and are not predictions of actual performance.

LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading Risk Factors in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (the SEC), and other risks described in documents subsequently filed or furnished by the Company from time to time with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations ContactYiyang Wang, Ph.D.LakeShore Biopharma Co., Ltd.Tel: +8618202433385Email: [email protected]



Source link

Tags: ApplicationAuthoritybiologicsbiopharmadruginitiatesInvesting.comLakeShorelicensePakistanPIKARabiesRegulatoryVaccine
ShareTweetShare
Previous Post

Bank of England cuts rates but sees higher inflation after Reeves’s budget By Reuters

Next Post

The State of Corporate ESG report: Key findings for CFOs

Related Posts

edit post
Finance Ministry eases rules for bonus share issue by companies in FDI-barred sectors

Finance Ministry eases rules for bonus share issue by companies in FDI-barred sectors

by TheAdviserMagazine
June 12, 2025
0

The finance ministry has amended rules to allow Indian companies, engaged in sectors where the foreign direct investment (FDI) is...

edit post
Mark Zuckerberg has an AI talent problem—but money alone is unlikely to solve it

Mark Zuckerberg has an AI talent problem—but money alone is unlikely to solve it

by TheAdviserMagazine
June 12, 2025
0

Welcome to Eye on AI! In this edition…Disney and Universal join forces in lawsuit against AI image creator Midjourney…France’s Mistral...

edit post
Shell to boost LNG capacity to 12mt by 2030

Shell to boost LNG capacity to 12mt by 2030

by TheAdviserMagazine
June 12, 2025
0

Oil and gas company Shell has announced plans to expand its capacity by up to 12 million tonnes (mt) by...

edit post
Fiverr leases space on Wix campus

Fiverr leases space on Wix campus

by TheAdviserMagazine
June 12, 2025
0

Israeli freelancer platform Fiverr (NYSE: FVRR) is moving out of central Tel Aviv to Glilot just north of the...

edit post
Oil tanker stocks on watch due to Mideast warnings, signs of potential attack on Iran (FRO:NYSE)

Oil tanker stocks on watch due to Mideast warnings, signs of potential attack on Iran (FRO:NYSE)

by TheAdviserMagazine
June 12, 2025
0

Jun. 12, 2025 8:32 AM ETFrontline plc (FRO) Stock, NAT StockTK, DHT, TEN, DAC, STNG, ASC, INSW, TRMD, HAFNBy: Carl...

edit post
‘Ghost’ students are hijacking millions from colleges—and locking real human students out of classes

‘Ghost’ students are hijacking millions from colleges—and locking real human students out of classes

by TheAdviserMagazine
June 12, 2025
0

Scammers disguised as thousands of fake students are flooding colleges across the U.S. with enrollment applications. The “students” are registering...

Next Post
edit post
The State of Corporate ESG report: Key findings for CFOs

The State of Corporate ESG report: Key findings for CFOs

edit post
Trump adviser says Powell will likely keep Fed role until 2026

Trump adviser says Powell will likely keep Fed role until 2026

  • Trending
  • Comments
  • Latest
edit post
Squatters Can Legally Take Your Home In These 8 States

Squatters Can Legally Take Your Home In These 8 States

May 18, 2025
edit post
15 “As Seen On TV” Products That Are Well Worth The Money

15 “As Seen On TV” Products That Are Well Worth The Money

May 24, 2025
edit post
LPL, Edward Jones, others to pay M-plus for overcharges

LPL, Edward Jones, others to pay $9M-plus for overcharges

June 10, 2025
edit post
Retiring at 65 Could Become the New Financial Suicide

Retiring at 65 Could Become the New Financial Suicide

May 19, 2025
edit post
Why Baby Boomers Are Hoarding Wealth While Their Kids Can’t Afford Groceries

Why Baby Boomers Are Hoarding Wealth While Their Kids Can’t Afford Groceries

May 24, 2025
edit post
Josh Hawley blasts Allstate CEO for making M last year — while company can’t ‘afford’ to pay out claims

Josh Hawley blasts Allstate CEO for making $26M last year — while company can’t ‘afford’ to pay out claims

May 21, 2025
edit post
Healthy Paws pet insurance review 2025

Healthy Paws pet insurance review 2025

0
edit post
*RARE* Bogg Bags as low as .99!

*RARE* Bogg Bags as low as $40.99!

0
edit post
Why Real Estate Investors Should Pay Close Attention to NAR, Zillow, and the Battle Over Listing Rules

Why Real Estate Investors Should Pay Close Attention to NAR, Zillow, and the Battle Over Listing Rules

0
edit post
What’s in a name: From verify to IAM – how Veriam simplified its identity with intent

What’s in a name: From verify to IAM – how Veriam simplified its identity with intent

0
edit post
What To Know About Trump’s New Cybersecurity Executive Order

What To Know About Trump’s New Cybersecurity Executive Order

0
edit post
Could Trump’s New Tax Bill Spark a Real Estate Revival?

Could Trump’s New Tax Bill Spark a Real Estate Revival?

0
edit post
*RARE* Bogg Bags as low as .99!

*RARE* Bogg Bags as low as $40.99!

June 12, 2025
edit post
Solana-Linked  Billion DeFi Dream Crushed By SEC Intervention

Solana-Linked $1 Billion DeFi Dream Crushed By SEC Intervention

June 12, 2025
edit post
Finance Ministry eases rules for bonus share issue by companies in FDI-barred sectors

Finance Ministry eases rules for bonus share issue by companies in FDI-barred sectors

June 12, 2025
edit post
Mark Zuckerberg has an AI talent problem—but money alone is unlikely to solve it

Mark Zuckerberg has an AI talent problem—but money alone is unlikely to solve it

June 12, 2025
edit post
Confident, Cautious or Confused? What to Make of Mixed Market Signals

Confident, Cautious or Confused? What to Make of Mixed Market Signals

June 12, 2025
edit post
Here are the three reasons why tariffs have yet to drive inflation higher

Here are the three reasons why tariffs have yet to drive inflation higher

June 12, 2025
The Adviser Magazine

The first and only national digital and print magazine that connects individuals, families, and businesses to Fee-Only financial advisers, accountants, attorneys and college guidance counselors.

CATEGORIES

  • 401k Plans
  • Business
  • College
  • Cryptocurrency
  • Economy
  • Estate Plans
  • Financial Planning
  • Investing
  • IRS & Taxes
  • Legal
  • Market Analysis
  • Markets
  • Medicare
  • Money
  • Personal Finance
  • Social Security
  • Startups
  • Stock Market
  • Trading

LATEST UPDATES

  • *RARE* Bogg Bags as low as $40.99!
  • Solana-Linked $1 Billion DeFi Dream Crushed By SEC Intervention
  • Finance Ministry eases rules for bonus share issue by companies in FDI-barred sectors
  • Our Great Privacy Policy
  • Terms of Use, Legal Notices & Disclosures
  • Contact us
  • About Us

© Copyright 2024 All Rights Reserved
See articles for original source and related links to external sites.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
No Result
View All Result
  • Home
  • Financial Planning
    • Financial Planning
    • Personal Finance
  • Market Research
    • Business
    • Investing
    • Money
    • Economy
    • Markets
    • Stocks
    • Trading
  • 401k Plans
  • College
  • IRS & Taxes
  • Estate Plans
  • Social Security
  • Medicare
  • Legal

© Copyright 2024 All Rights Reserved
See articles for original source and related links to external sites.