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Sinovac Biotech

Sinovac Biotech Ltd is a China-based biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including, without limitation, hepatitis A, hepatitis B, hand foot and mouth disease (HFMD) caused by EV71, seasonal influenza, H5N1 and H1N1 pandemic influenza, coronavirus, pneumococcus, poliomyelitis, varicella and mumps.

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<ul>
<li>Vivo Capital Challenges SINOVAC's Paying Agent on Distribution of the Dividend</li>
<li>Opposition Brief to be Filed Monday in Advance of Wednesday Hearing and Expected Friday Decision</li>
</ul>

News

SINOVAC Board Warns Shareholders As Advantech And Vivo Capital Legal Action Threatens $55.00 Special Dividend Distribution

In summary:
<ul>
<li>We urge shareholders not to be misled by the Vivo group's attempts to relitigate an unappealable verdict by the Privy Council, rewrite history, and paint a fictitious picture of the last few years' events, while simultaneously attempting to line their own pockets at your expense.</li>
<li>It is our fiduciary duty to vigorously defend against the hostile actions and lawsuits by the Vivo group so that we may ensure fairness for all shareholders, restore integrity and trust, and position SINOVAC for the future.</li>
<li>We are confident we will prevail, and we want to emphasize that we are urgently working to make things right as soon as possible to mitigate against further chaos and litigation, after what we have all endured over the last seven years.</li>
</ul>

SINOVAC Board Responds To Vivo Capital's Legal Threats, Defends $55/Share Special Dividend For Common Shareholders

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SVRA

CORRECTION: Savara Ticker Is "SVRA"

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SINOVAC Board Declares $55 Dividend, Pledges Shareholder Access To Future Subsidiary Payouts

SINOVAC Says Determined To Maintain Transparency And Uphold High Standards Of Corporate Governance Under Leadership Of New Board

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Sinovac Biotech Kicked Off The Enrollment For A Phase 3 Trial On A Vaccine Candidate To Prevent Hand-Foot-Mouth Disease Caused By Both Enterovirus 71 And Coxsackievirus 16

Earnings

SINOVAC H1 EPS $(0.11) Down From $(0.15) YoY; Sales $121.3M Down From $140.4M YoY

Sinovac Biotech Ltd. (&quot;SINOVAC&quot; or the &quot;Company&quot;) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>), a leading provider of biopharmaceutical products in China, announced that the Company has completed the phase I clinical trial for its broad-spectrum neutralizing antibody product, the Anti-COVID-19 Antibody SA55 Injection (&quot;SA55 Injection&quot;) in Beijing and has entered the phase II clinical trial in Shanghai after successfully enrolling its first participant recently.
SINOVAC&#39;s SA55 Injection, which is intended for the treatment of COVID-19 infections, was approved for clinical trial in China on May 24, 2023. The phase I clinical trial has confirmed its preliminary safety profile in 40 healthy adults aged 18 to 65 in China.
The phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study. It is expected to enroll 150 patients aged 18 and above with mild to moderate COVID-19 infection from nearly 20 medical institutions in China. Participants will be randomly assigned to groups receiving different dosages of SA55 Injection or placebo to evaluate its ability to decrease SARS-CoV-2 virus loads and alleviate clinical symptoms, while assessing its safety. Preliminary results are anticipated by the year&#39;s end.

SINOVAC Updates on the Clinical Trial Progress of its Anti-COVID-19 Antibody SA55 Injection

Sinovac Biotech Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>) (&quot;SINOVAC&quot; or the &quot;Company&quot;), a leading provider of biopharmaceutical products in China, announced today that its Board of Directors (the &quot;Board of Directors&quot;) unanimously determined that the partial tender offer (the &quot;Tender Offer&quot;) by Alternative Liquidity Index LP (&quot;Alternative Liquidity&quot;) to acquire up to 10,000,000 common shares of Sinovac (the &quot;Shares&quot;) for&nbsp;$0.03&nbsp;per share in cash (the &quot;Offer Price&quot;) is&nbsp;NOT&nbsp;advisable and is&nbsp;NOT&nbsp;in the best interests of the Company or its shareholders (&quot;Shareholders&quot;). Accordingly, the Board of Directors recommends that the Shareholders reject the Tender Offer and not tender their Shares for purchase pursuant to the Offer to Purchase by Alternative Liquidity.

Sinovac Biotech Board Unanimously Rejects an Unsolicited Partial Tender Offer from Alternative Liquidity Index To Acquire up to 10M Shares of Sinovac Biotech for $0.03/Share in Cash

Sinovac Biotech Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>) (&quot;SINOVAC&quot; or the &quot;Company&quot;), a leading provider of biopharmaceutical products in China, confirmed today that it is aware of an unsolicited partial tender offer from Alternative Liquidity Index LP to purchase up to a maximum of 10,000,000 shares of the Company, representing approximately&nbsp;10.05%&nbsp;of the Company&#39;s outstanding shares, for&nbsp;$0.03&nbsp;per share in cash.

Alternative Liquidity Index Offers To Acquire up to 10M Shares of Sinovac Biotech for $0.03/Share in Cash

<h4>Key Takeaways:</h4>
<ul>
<li>News of marketing approval for China&rsquo;s first mRNA vaccine falls flat with investors, who worry the drug is being rushed to market before Phase 3 trials are complete</li>
<li>As the pandemic abates, the market for the vaccine is shrinking rapidly</li>
</ul>
By Ellie Si
Timing is everything, so the saying goes, and it&rsquo;s certainly true for the maker of China&rsquo;s first domestically developed mRNA vaccine against Covid.
CSPC Pharmaceutical Group Ltd.&nbsp;(1093.HK) announced last week it had gained regulatory&nbsp;<a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0322/2023032200185.pdf">approval</a>&nbsp;to market its new Covid vaccine, beating a host of rivals to become the first commercial producer of a Chinese-made mRNA drug. The company also reported a revenue rise for last year. Under different circumstances the news would have triggered a market rally, but the share price plunged instead.
Coming at the tail end of the pandemic rather than at its height, the emergency-use approval for the mRNA vaccine fell flat with investors, who were worried about the speed at which the drug was being brought to market.
The day after the news, the stock plummeted 7.3% to HK$7.74, shrinking the company&rsquo;s market valuation to barely HK$90 billion ($11.5 billion).
The level of pandemic risk is a key factor. Most Chinese have already been immunized with other anti-Covid vaccines. Meanwhile, the government removed strict pandemic controls last December and has since reported no major outbreaks. The scope for the vaccine market is contracting rapidly, leaving investors pessimistic about the profit prospects.
CSPC is a major Chinese pharmaceutical company with a range of products in development production or sales. The company&rsquo;s website describes 36 products for various diseases that have generated sales of more than 100 million yuan ($14.5 million).
When it announced the vaccine approval, CSPC Pharma also published&nbsp;<a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0322/2023032200225.pdf">annual results</a>&nbsp;showing that its revenue grew 11% to 30.9 billion yuan last year. The figure included 24.5 billion yuan in revenue from the business of finished drugs, which was up by 8.1%, and 4.45 billion yuan related to its bulk products, a rise of 16.5%.
<h4>Less Than A&nbsp;Year In Clinical Trials</h4>
The main earners are treatments for neurological conditions and cancers. Neurological drugs made up the biggest revenue share at 8.11 billion yuan, 7.5% more than the previous year, while revenue from cancer drugs dropped 3.8% to 7.42 billion yuan.
The company boasts many product pipelines that keep sending new drugs to market. Last year, it introduced a drug to treat T-cell lymphoma and another for follicular lymphoma. In addition, several of its generic drugs have been selected for the government&rsquo;s procurement program. The company has thus diversified its revenue streams and better balanced its product portfolio.
But investors have paid most attention to the Covid mRNA vaccine, SYS6006, which has become the first such domestically developed jab to be cleared for use in China. This type uses a lab-developed messenger RNA method to instruct cells to make specific antibodies, unlike vaccines that use a deactivated form of a virus.
The CSPC vaccine entered clinical trials in April 2022 with approval from China&rsquo;s National Medical Products Administration (NMPA). It raced through Phase 1 and 2 clinical trials in a matter of months, and was judged to be effective and safe in protecting against Covid infections.
The trials also probed the effects of having an mRNA injection after doses of other Covid vaccines.
Most of the vaccines administered in China were based on inactivated forms of the virus, using products developed by&nbsp;Sinopharm&nbsp;(1099.HK) and&nbsp;Sinovac&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sva#NASDAQ">SVA</a>), as well as an adenovirus vector vaccine from&nbsp;CanSino Biologics&nbsp;(6185.HK; 688185.SH). Therefore, tests to determine the booster impact of an mRNA vaccine were particularly significant.
The company said 4,000 booster trial sessions were conducted during the pandemic with recombinant protein vaccines as the control and an observation period of 28 days. The CSPC Pharma vaccine was shown to have a protection effect of 70.2% seven to 28 days after injection, rising to 85.3% after 14 to 28 days. And researchers found that an mRNA injection after two or three doses of other inactivated-virus vaccines can better fight variants such as Omicron.
<h4>Demand Weakens As Pandemic Abates</h4>
However, the fast progress has caused concerns among investors. Firstly, the vaccine is yet to complete larger scale Phase 3 clinical trials. Even if it is proven to be highly effective, the vaccine enters a shrinking market now that the pandemic has retreated across the world.
In technology terms, mRNA is the cutting edge of immunization. Covid mRNA vaccines made by&nbsp;Pfizer&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) in partnership with&nbsp;BioNTech&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>), or by drugmaker&nbsp;Moderna&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>), were successfully marketed during the pandemic. Pfizer&rsquo;s mRNA vaccine contributed $37.8 billion to its 2022 revenue, nearly 40% of the total.
The mRNA vaccines sold overseas are still not available in mainland China. In 2020,&nbsp;Fosun Pharma&nbsp;(2196.HK; 600196.SH) paid tens of millions of dollars to BioNTech for the exclusive right to develop and commercialize the Covid vaccine Comirnaty in China. But after three years the vaccine is still only available in Hong Kong, Macau and Taiwan.
That explains why many Chinese companies joined a gold rush to develop mRNA vaccines. Abogen Biosciences, an early competitor, got more $700 million and $300 million in two rounds of fundraising in 2021, sending its valuation above $20 billion.
So far this year, CanSino,&nbsp;Walvax Biotechnology&nbsp;(300142.SZ) and Sinopharm have also reported progress in developing Covid mRNA vaccines. But CSPC Pharma is the first contender to bring its vaccine to market. Though late out of the starting blocks, it crossed the approval finishing line less than a year after launching clinical trials.
But even the winners cannot dodge the rapidly contracting market for Covid vaccines.
Trailblazer Pfizer, which reported more than $100 billion in revenue last year, has cut its forecast for this year to between $67 billion and $71 billion on an expected drop in Covid-related income. The Chinese vaccine producer CanSino already reported a loss last year due to the slowdown in the Covid vaccine market, and its share price has fallen by more than 90% from the HK$450 peak in 2021.
The marketing approval for CSPC Pharma&rsquo;s mRNA vaccine is a breakthrough for China&rsquo;s domestic drug industry. But the achievement was ultimately outpaced by the pandemic, which has now passed its peak, limiting the money-making potential for Covid vaccines.

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CSPC Pharma Wins China's mRNA Vaccine Race, But Just Not Fast Enough

Sinovac Biotech Board Amends Shareholder Rights Plan, Extends Expiration Date From February 22, 2023 To February 22, 2024

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Benzinga's Top Ratings Upgrades, Downgrades For January 5, 2023

COVID-19 cases have spiked again in China, sparking&nbsp;fresh lockdown measures in the nation&#39;s capital.&nbsp;Jim Cramer has suggested that Chinese President&nbsp;Xi Jinping&nbsp;isn&#39;t telling the whole story.&nbsp;
&quot;I don&#39;t know what&#39;s with President Xi other than the fact that it would be a terrible admission that their vaccines don&#39;t work,&quot; Cramer said Tuesday on CNBC&#39;s &quot;Squawk On The Street.&quot;
What To Know:&nbsp;<a href="https://www.benzinga.com/topic/covid-19" target="_blank">COVID-19</a>&nbsp;cases have been rising in multiple districts throughout China.&nbsp;On Monday, Beijing&nbsp;officials&nbsp;urged residents of the Chaoyang district&nbsp;to stay at home, extending a request from the weekend.&nbsp;The Haizhu district in&nbsp;Guangzhou also extended its <a href="https://www.benzinga.com/topic/covid-19">COVID-19</a> restrictions in some areas to Nov. 27, according to local reports.
Beijing, the capital of China,&nbsp;reported more than <a href="https://www.benzinga.com/markets/asia/22/11/29815850/alibaba-nio-fall-over-3-hang-seng-opens-weaker-as-focus-turns-to-fed-minutes-china-covid-19-cases">600&nbsp;new&nbsp;COVID cases</a> on Tuesday. Several reports indicate that Beijing&nbsp;will require individuals to show&nbsp;a negative PCR test&nbsp;within the last 48 hours&nbsp;to enter public venues&nbsp;like&nbsp;shops,&nbsp;hotels&nbsp;and government offices.&nbsp;
See Also:&nbsp;<a href="https://www.benzinga.com/markets/asia/22/11/29815850/alibaba-nio-fall-over-3-hang-seng-opens-weaker-as-focus-turns-to-fed-minutes-china-covid-19-cases">Alibaba, Nio Fall Over 3%: Hang Seng Opens Weaker As Focus Turns To Fed Minutes, China COVID-19 Cases</a>
The new restrictions come&nbsp;after Beijing reported three COVID-related deaths over the weekend, its first deaths reportedly caused by the virus since May.&nbsp;
&quot;Can they tell the truth about anything? Three. I mean three people die like every 10 seconds of COVID,&quot; Cramer said.&nbsp;
For some perspective, the U.S. has reported more than 1 million deaths due to COVID-19 since the start of the pandemic.&nbsp;The current seven-day average of new deaths is&nbsp;317, according to the CDC.
Cramer suggested the numbers out of China are wrong and&nbsp;the&nbsp;<a href="https://www.benzinga.com/coronavirus-covid-19">continued spikes</a> in COVID cases and subsequent lockdown measures show that the situation isn&#39;t under control.&nbsp;It&#39;s time for China to start using the vaccines that actually work, Cramer said.&nbsp;
Why It Matters: CoronaVac is the most&nbsp;widely used COVID-19 vaccine in China. It&#39;s&nbsp;made&nbsp;by Beijing-based firm&nbsp;Sinovac Biotech&nbsp;Ltd (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sva#NASDAQ">SVA</a>). The only other approved vaccine in China&nbsp;comes from&nbsp;state-owned Sinopharm Group Co Ltd (Pink: <a class="ticker" href="https://www.benzinga.com/stock/shtdy#Pink">SHTDY</a>).&nbsp;
The WHO&nbsp;approved the vaccines&nbsp;for emergency use&nbsp;on&nbsp;limited clinical-trial data in mid-2021, showing that CoronaVac was about 50% effective and Sinopharm was just below 80% effective.&nbsp;
For comparison, data for&nbsp;Pfizer&nbsp;Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) and&nbsp;BioNTech SE&#39;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>) COVID-19 vaccine, as well as Moderna Inc&#39;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) mRNA vaccine, showed&nbsp;more than 90% efficacy on approval.
&quot;I mean they <a href="https://www.benzinga.com/general/biotech/22/10/29114210/moderna-says-no-to-chinas-request-to-handover-covid-19-vaccine-technology-report">reverse engineered</a> the Pfizer vaccine, the mRNA vaccine, they have it. I do not understand why they won&#39;t give it to everybody,&quot; Cramer said.
He noted&nbsp;that Xi has the <a href="https://www.benzinga.com/general/biotech/22/09/28861480/ceo-says-capacity-available-to-supply-covid-19-shots-to-the-most-populated-country">ability to end</a> the continued COVID-19 problems in China, but&nbsp;suggested that pride might be getting in the way.&nbsp;
&quot;So I don&#39;t know how much longer this lockdown nonsense is going to continue because it&#39;s really up to him,&quot; he said.
Check This Out:&nbsp;<a href="https://www.benzinga.com/news/22/11/29816257/tesla-china-demand-not-budging-ev-maker-reportedly-mulls-another-price-cut-as-order-intake-remains-a">Tesla China Demand Not Budging? EV Maker Reportedly Mulls Another Price Cut As Order Intake Remains Anemic</a>
Photo:&nbsp;<a href="https://www.flickr.com/photos/30478819@N08/" id="yui_3_16_0_1_1668095854203_835566" title="Go to Marco Verch Professional Photographer's photostream">Marco Verch</a>&nbsp;from Flickr.

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Jim Cramer Says China's Vaccines 'Don't Work' But Xi Won't Admit It

Sinovac Biotech Ltd. (&quot;SINOVAC&quot; or the &quot;Company&quot;) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>), a leading provider of biopharmaceutical products in China, today announced that it received prequalification from the World Health Organization (WHO) for its live attenuated varicella vaccine on November 3, 2022. This marks the first WHO prequalified Chinese varicella vaccine and the fourth SINOVAC vaccine to receive WHO approval.
The varicella vaccine is derived from the Oka strain and propagated in SINOVAC&#39;s proprietary Human Diploid Cell (SV-1 strain), which is made by culturing and harvesting the virus, adding stabilizers and freeze-drying.
According to a phase III efficacy study, the seroconversion rate of the vaccinated children group, ages 1 to 12 years old, was&nbsp;97.1%; the efficacy of the vaccine was&nbsp;87.1%&nbsp;against varicella and&nbsp;89.2%&nbsp;for breakthrough varicella. The vaccine provides&nbsp;100%&nbsp;protection against moderate and severe cases.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, &quot;Now that SINOVAC has received WHO prequalification for our varicella vaccine, we can provide a new weapon for prevention and control of infectious diseases globally. In the future, we will continue to work on more clinical trials, registrations and approvals for vaccines worldwide, to offer the world high-quality vaccines and ensure the accessibility and affordability of these public goods.&quot;
Previously, three other vaccines by SINOVAC were also approved by WHO in various uses and conditions, including Healive&reg; (the hepatitis A vaccine), CoronaVac&reg; (the COVID-19 vaccine) and the Sabin-strain inactivated polio vaccine.
SINOVAC has been acting on its mission to &quot;Supply Vaccines to Eliminate Human Diseases&quot;. So far, SINOVAC&#39;s vaccines have been distributed to more than 80 countries and regions around the world. The Company offers high-quality and affordable vaccines for global prevention and control of infectious diseases.

Reported Late Thursday, Sinovac Biotech's Varicella Vaccine Prequalified By WHO

Sinovac Biotech Ltd. (&ldquo;SINOVAC&rdquo; or the &ldquo;Company&rdquo;) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>), a leading provider of biopharmaceutical products in China, announced that the Chilean Public Health Institute (Instituto de Salud P&uacute;blica, ISP) approved a phase II clinical trial for its inactivated Omicron strain COVID-19 vaccine and trivalent COVID-19 vaccine (ancestral, Delta and Omicron variants) on August 31st. The clinical trial will evaluate the immunogenicity and safety of one booster dose of the two candidate vaccines in adults who had received two booster doses of CoronaVac&reg;, mRNA, or adenovirus vector COVID-19 vaccine. This study is the world&#39;s first study researching multivalent inactivated COVID-19 vaccine.
In this phase II randomized, double-blind, multicenter clinical trial, 826 fully vaccinated adults will be recruited. Participants belonging to the heterologous scheme are individuals who had received two CoronaVac&reg; doses, and two boosters of mRNA-based or viral vector-based vaccines, while participants of the homologous scheme had received four doses of CoronaVac&reg;. Individuals from the heterologous scheme will randomly receive a booster dose with the Omicron, Trivalent, or CoronaVac&reg; vaccines, while individuals from the homogeneous group will randomly receive a booster dose of the Omicron or the trivalent vaccines.
Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC said, &ldquo;SINOVAC has made great progress collaborating with global partners in the development and manufacturing of the COVID-19 vaccine. We are proud of the fact that CoronaVac&reg; can protect individuals as young as 6 months of age and this clinical approval will allow even better vaccine protection.&rdquo;

SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:
<h1>Stocks In Focus</h1>
<h3>Alnylam Reports Upbeat Data From&nbsp;Amyloidosis Study</h3>
Alnylam Pharmaceuticals Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alny#NASDAQ">ALNY</a>) APOLLO-B Phase 3 study of patisiran for transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/b28327147/alnylam-reports-positive-topline-results-from-apollo-b-phase-3-study-of-patisiran-in-patients-with" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">met the primary endpoint</a>&nbsp;of change from baseline in the 6-Minute Walk Test (6-MWT) at 12 months compared to placebo.&nbsp;
The study also met the first secondary endpoint of change from baseline in quality of life compared to placebo.
Patisiran also demonstrated an encouraging safety and tolerability profile, with deaths numerically favoring the patisiran arm.
The company plans to file a supplemental marketing application with the FDA in late 2022.
Shares are up 45.8% at $207.00 during the premarket session.
<h3>Sinovac&#39;s COVID-19 Shot Approved For Kids Below 3 Years&nbsp;</h3>
The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/b28325998/sinovac-covid-19-vaccine-approved-for-use-in-children-above-6-months-of-age-in-hong-kong" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">regulatory authority in Hong Kong has approved</a>&nbsp;Sinovac Biotech Ltd&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sva#NASDAQ">SVA</a>) COVID-19 vaccine (CoronaVac), intended for children aged six months to 3 years.
Three doses of vaccines will be used, with the first two doses given 28 days apart, followed by a third dose at least three months after the second dose.
<h3>FDA Approves Coherus&#39; Lucentis Referenced Biosimilar</h3>
The&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/g28323062/fda-approves-coherus-cimerli-ranibizumab-eqrn-as-the-first-and-only-interchangeable-biosimilar-to-" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">FDA has approved</a>&nbsp;Coherus BioSciences Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/chrs#NASDAQ">CHRS</a>) Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with&nbsp;Roche Holding AG&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) Lucentis for five retina indications.
Cimerli belongs to the anti-VEGF therapy class of biologics.
Commercial availability of Cimerli, in both 0.3 and 0.5 mg dosages, is planned for early October 2022.
<h3>Rigel Pharma Expanded Hematology-Oncology Portfolio With License Pact</h3>
Rigel Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rigl#NASDAQ">RIGL</a>) and&nbsp;Forma Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fmtx#NASDAQ">FMTX</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/n28318934/rigel-pharmaceuticals-and-forma-therapeutics-announce-licensing-agreement-for-olutasidenib-a-novel" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">entered into an exclusive, worldwide license agreement</a>&nbsp;to develop, manufacture and commercialize olutasidenib.
Forma will receive an upfront payment of $2.0 million and is eligible to receive an additional $17.5 million as near-term regulatory, approval, and first commercial sale milestones.&nbsp;
In addition, Forma is eligible to receive up to an additional $215.5 million in development and commercial milestones.&nbsp;
<h3>Merck&#39;s Two Keytruda Combo Cancer Trials Miss Primary Goal</h3>
Merck &amp; Co Inc&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) Phase 3 KEYNOTE-921 trial of Keytruda combined with chemotherapy (docetaxel)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/b28326745/merck-provides-update-on-phase-3-keynote-921-trial-evaluating-keytruda-pembrolizumab-plus-chemothe" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">did not meet its dual primary endpoints</a>&nbsp;of overall survival (OS) and radiographic progression-free survival (rPFS) for metastatic castration-resistant prostate cancer.
Separately, Merck and&nbsp;Eisai Co Ltd&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/esaly#OTC">ESALY</a>) Phase 3 LEAP-002 trial of Keytruda plus Lenvima&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/b28326822/merck-and-eisai-provide-update-on-phase-3-leap-002-trial-evaluating-keytruda-pembrolizumab-plus-le" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">did not meet its dual primary endpoints</a>&nbsp;of OS and PFS in unresectable hepatocellular carcinoma.
<h3>Regenxbio Plans To File Application For Hunter Syndrome Gene Therapy In 2024</h3>
Regenxbio Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rgnx#NASDAQ">RGNX</a>) intends to&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/n28327343/regenxbio-announces-intention-to-file-a-biologics-license-application-using-the-accelerated-approv" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">file a marketing application in 2024</a>&nbsp;using the FDA&#39;s accelerated approval pathway for RGX-121 for Mucopolysaccharidosis Type II, known as Hunter Syndrome.&nbsp;
The company also announced that a pivotal program for RGX-121 is active and enrolling patients. RGX-121 is an investigational, one-time AAV Therapeutic using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase enzyme.
Also Read:&nbsp;<a href="https://www.benzinga.com/news/22/08/28325892/top-questions-tesla-shareholder-want-musk-team-to-address-at-thursdays-annual-shareholder-meeting">Top Questions Tesla Shareholder Want Musk, Company Leaders To Address At Thursday&#39;s Annual Shareholder Meeting</a>
<h3>Poseida Shares Rally As Roche Takes Next Big Step Into Allogeneic CAR-T Field</h3>
Poseida Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pstx#NASDAQ">PSTX</a>) has entered into a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/n28328119/poseida-therapeutics-announces-strategic-global-collaboration-with-roche-focused-on-allogeneic-car" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">strategic collaboration and license agreement</a>&nbsp;with&nbsp;Roche Holdings AG&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>), focused on developing allogeneic CAR-T therapies directed to hematologic malignancies.&nbsp;
Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize several allogeneic CAR-T programs in Poseida&#39;s portfolio.
Poseida will receive $110 million upfront and could receive up to $110 million in near-term milestones.
In addition, Poseida is eligible to receive up to $6 billion in milestone payments.
PSTX shares are up 73.7% at $4.22 during the premarket session.
<h3>Offering</h3>
Arcutis Biotherapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arqt#NASDAQ">ARQT</a>) priced its underwritten public offering of 7.5 million at $20 per share, with gross proceeds of $150.
Kintara Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ktra#NASDAQ">KTRA</a>) entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC
Shares surged 119% to 39 cents during the premarket session.
<h3>On The Radar</h3>
<h3>PDUFA Dates</h3>
Sanofi SA&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) and&nbsp;Regeneron Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>): Supplemental application for Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in patients 12 years and above.
<h3>Earnings</h3>
United Therapeutics Corporation&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/uthr#NASDAQ">UTHR</a>):&nbsp;Before the market open.
Eyepoint Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/eypt#NASDAQ">EYPT</a>):&nbsp;Before the market open.
Seres Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mcrb#NASDAQ">MCRB</a>):&nbsp;Before the market open.
Intercept Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/icpt#NASDAQ">ICPT</a>):&nbsp;Before the market open.
Editas Medicine Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/edit#NASDAQ">EDIT</a>):&nbsp;Before the market open.
Horizon Therapeutics PLC&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hznp#NASDAQ">HZNP</a>):&nbsp;Before the market open.
Amarin Corporation plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amrn#NASDAQ">AMRN</a>):&nbsp;Before the market open.
Regeneron Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>):&nbsp;Before the market open.
Moderna Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>):&nbsp;Before the market open.
Jazz Pharmaceuticals PLC&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/jazz#NASDAQ">JAZZ</a>): After market close.
Arcus Biosciences Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rcus#NYSE">RCUS</a>): After market close.
Mirati Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrtx#NASDAQ">MRTX</a>): After market close.
Regenxbio Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rgnx#NASDAQ">RGNX</a>): After market close.
Fate Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fate#NASDAQ">FATE</a>): After market close.
Vanda Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vnda#NASDAQ">VNDA</a>): After market close.
Biomarin Pharmaceutical Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bmrn#NASDAQ">BMRN</a>): After market close.

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Biotech Daily: Merck's Two Combo Cancer Trials Miss Main Goal, Approval For Sinovac's COVID-19 Shot For Youngest Kids, Alnylam Aces Protein Disorder Trial

Sinovac Biotech Ltd. (&quot;SINOVAC&quot; or the &quot;Company&quot;) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVA#NASDAQ">SVA</a>), a leading provider of biopharmaceutical products in China, announced that based on related clinical trials and studies of vaccination for local children and adolescents, the Health Bureau of the Government of the Hong Kong Special Administrative Region of the People&#39;s Republic of China has approved the Company&#39;s COVID-19 vaccine (CoronaVac), intended for children aged 6 months to 3 years.
The vaccination schedule for this age group follows the same vaccination schedule of older children. Three doses of vaccines will be used for children aged six months to under three years of age, with the first two doses given 28 days apart followed by a third dose at least 3 months after the second dose, and there is no restriction on the application for immunosuppressed children.
The Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases under the Centre for Health Protection of the Department of Health, joined by the Chief Executive&#39;s expert advisory panel, issued the&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.info.gov.hk%2Fgia%2Fgeneral%2F202208%2F01%2FP2022080100675.htm&amp;esheet=52800068&amp;newsitemid=20220803005368&amp;lan=en-US&amp;anchor=consensus+interim+recommendations&amp;index=1&amp;md5=2af7a18e037cfafde400e189da96e2da">consensus interim recommendations</a>&nbsp;on the use of COVID-19 vaccines for children aged 6 months or above in Hong Kong on August 1, 2022.
SINOVAC initiated its COVID-19 vaccine (CoronaVac) phase III clinical studies among children aged 6 months to 17 years since 2021. Preliminary results show the vaccine has a good safety and immunogenicity profile, with no severe adverse reaction reported 6 months after two doses of vaccination among children aged 6 months to 35 months.
CoronaVac has been authorized for emergency use for minors and adults above 3 years old in Hong Kong since February 15, 2022. As of August 2022, CoronaVac has been approved for use in minors in 14 countries in Latin America that include Chile, Colombia, Ecuador, Brazil, as well as in other countries in the Asia and Africa regions.
&nbsp;

SINOVAC COVID-19 Vaccine Approved For Use In Children Above 6 months Of Age in Hong Kong

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New Oriental Education & Technology Group

NTES

Citigourp Global Markets 2% Protected Notes Linked To The Djia

Shares of Chinese companies are trading lower after President Xi held an economic meeting yesterday and did not indicate an economic growth stimulus was imminent. China also reiterated the 'zero-COVID policy'

<ul>
<li>COVID-19 vaccines from&nbsp;AstraZeneca Plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) and&nbsp;Pfizer Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) saved an estimated 12 million lives,&nbsp;<a class="editor-rtfLink" href="https://www.bloomberg.com/news/articles/2022-07-13/astra-s-covid-vaccine-saved-over-six-million-lives-in-first-year#xj4y7vzkg?sref=TBDibEcD" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Bloomberg reported</a>&nbsp;citing a new analysis from Airfinity Ltd.</li>
<li>The AstraZeneca vaccine developed by the University of Oxford saved 6.3 million lives, Airfinity said. The estimate for the Pfizer-BioNTech SE (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>) shot was 5.9 million.&nbsp;</li>
<li>According to the report, the companies swiftly scaled up production and delivered doses before other manufacturers.&nbsp;</li>
<li>The findings build on a study last month estimating that vaccines saved about 20 million lives in the first year, mostly in wealthier countries.</li>
<li>More than 7 million deaths were likely averted in countries covered by Covax, the World Health Organization-backed distribution program highlighting the uneven access.&nbsp;</li>
<li>The data shows that about one in five lives lost due to Covid in poorer countries could have been prevented if WHO targets had been reached.</li>
<li>Airfinity determined that the vaccines of&nbsp;Sinovac Biotech Ltd&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sva#NASDAQ">SVA</a>) and&nbsp;Moderna Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) saved about 2 million and 1.7 million lives, respectively.</li>
<li>Photo by Johaehn from Pixabay</li>
</ul>

AZNCF

Which COVID-19 Vaccine(s) Significantly Prevented Deaths - Read To Find Out

Press Releases

SINOVAC's Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders

Prime Success Responds to Sinovac Biotech's False and Misleading Claims

SINOVAC Board of Directors Alerts Shareholders to Advantech/Prime Success' New Lawsuit, Which Threatens to Prevent Payment of US$55.00 Special Dividend to All Valid Shareholders

Heng Ren Calls on Sinovac to Pay Shareholders the Special Dividend Before the July 8 Board Vote

SAIF Partners Files Definitive Proxy Materials in Connection with Sinovac Biotech 2025 Special Meeting of Shareholders; Nominates Ten Highly Qualified Director Candidates to the Board

Prime Success Sets the Record Straight Regarding Continued False and Misleading Statements from Sinovac Biotech's Current Board

SINOVAC Board of Directors Provides Update on Special Dividend Payment and Commitment to Delivering Value to All Shareholders

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