Connect with us


Gracell Biotechnologies Receives Medical Products Manufacturing Certificate for CAR-T Cell Therapy Products



Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell”), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products. The certification was granted on January 4, 2021, and indicates that Gracell’s site in Suzhou Industrial Park (SIP) has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment.

Since the new Pharmaceutical Administration Law of the People’s Republic of China took effect on December 1, 2019, GMP certification has been abolished in China and applications for GMP certification are no longer accepted by the National Medical Products Administration (NMPA). Instead, the “Measures for Supervision and Management of Medical Products Manufacturing”, which came into effect on July 1, 2020, clearly outlines strict and detailed requirements regarding permissions and relevant supervisions for the manufacture of medical products. Only manufacturing sites that fully satisfy these stringent requirements can successfully pass an on-site inspection to obtain the “Medical Products Manufacturing Certificate”.

As of March 2020, Gracell has implemented a comprehensive Quality Management System that fully complies with the U.S. FDA cGMP, EU GMP, China GMP, and relevant global guidelines for cell therapy products.

Gracell’s Suzhou site underwent and successfully passed an on-site inspection conducted by JSMPA inspectors in November, 2020, and received its official “Medical Products Manufacturing Certificate” on January 4, making it one of five CAR-T cell therapy manufacturers nationwide to receive the license.

“Our passion is to change the way conventional CAR-T therapies have been manufactured, and provide effective, low cost manufacturing of cellular gene therapeutics with fast turnaround time,” said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “We are thrilled to receive this certificate from JSMPA, which will enable us to further advance our current clinical programs including our FasTCAR-T programs and bring transformative CAR-T cell therapies to a broader group of patients.”

About Gracell

Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

Cautionary Noted Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Media contact

Linc He

Investor contact

Gracie Tong

SOURCE Gracell Biotechnologies

This article appeared first on here.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *


This Week’s Earnings Repertoire



Last week ended with the Omicron Covid variant casting a shadow over the joy revolving around the upcoming holidays. This week, Costco (NASDAQ: COST), Stitch Fix (NASDAQ: SFIX), Lululemon Athletica (NASDAQ: LULU) and GameStop Corporation (NYSE: GME) will show how they are weathering global challenges that even got the big ones tripped up.

1. Stitch Fix

The online apparel specialist’s shares have been having a hard time this year, which means the bar is set low for its Tuesday report. Back in September, management expected sales growth to slow to as low as 15% in the new fiscal year, compared to last year’s 23%. Although that slowdown might be temporary, Wall Street is worried about the impact of slowing growth, rising competition, and pressured margins due to supply chain disruptions and inflationary costs.

Adding direct shopping offerings is expected to help the subscription-based apparel delivery service business unlock a much bigger addressable market. But as it faces off well-established rivals, Stitch Fix has fewer competitive advantages.

Everyone’s eyes will be on the engagement metrics such as average spending will help show whether Stitch Fix is succeeding in reaccelerating sales growth. But investors are doubting the business’ capability to recapture that 20% sales growth momentum, let alone go beyond it.

2. GameStop

After the bell on Wednesday, GameStop has a lot to prove as management is yet to show the real turnaround plan. The reinvigorated video game retailer classified by CNBC’s Jim Cramer as the “king of the meme stocks” is expected to report sales at $1.2 billion that resulted in a loss of 52 cents. The only thing certain is that the stock will move as investors are used to a wild ride with this stock that kicked off the year reaching for the stars, only to go on to shed nearly half of its value throughout the year.

3.  Costco’s inventory wins

Investors are expecting the warehouse retailer to report growth of 13% YoY that translates to sales of $49 billion. Expectations are high for the world’s second-biggest retailer when it reports its earnings on Thursday afternoon as its biggest competitor, Walmart (NYSE: WMT), recently revealed strong sales growth as it succeeded to overcomesupply and inventory challenges that have tripped up smaller peers. Costco likely handled these issues as it licenses its own shipping fleet earlier this year.

Moreover, any gains in renewal rate as well as online and physical customer traffic could lay the groundwork for higher membership fees that power most of Costco’s annual earnings.

4. Lululemon’s holiday outlook

After upgrading its 2021 outlook in its previous two earnings reports, Lululemon is expected to provide a third upgrade on Thursday. Annual sales guidance is currently at $6.3 billion which is a significant increase from $4.4 billion before the pandemic struck.

To further improve, Lululemon needs to show it can keep up the momentum on pricing after profitability soared to new highs. For the last reported quarter, gross profit margin made 58% of sales with operating profit being over 20% of revenue. This year’s stock rally is greatly owed to that success fueled by strong demand for its athleisure products but inflationary pressures threaten to spoil that “picture perfect” trend.

However, even if this is the case, growth avenues such as new geographies and new demographics likes menswear and outerwear can help Lululemon overcome those short-term constraints that will ease over the next few quarters. All in all, the retailer has plenty of room to run.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact:

Continue Reading


Omicron Casts a Shadow Over Salesforce’s Better-Than-Expected Q3 Results


on Inc (NYSE: CRM) has had the worst day since COVID-19 started its relentless march across the globe due to a disappointing guidance. Despite profit and revenue for the reported quarter exceeding expectations, its shares dropped 12% whereas time the stock had its worst day was March 16th, 2020, when the stock plummeted 16%.

Q3 results

What was largely ignored by the market was the fact that Salesforce produced big earnings beat with the help of Slack Technologies Inc. Fiscal third profit amounted to $468 million or 47 cents per share. Adjusted earnings amounted to $1.27 per share which is well ahead of estimates but below last year’s comparable quarter. Revenue amounted to $6.86 billion.

Disappointing Q4 guidance

Earnings per share for the December quarter are expected to be in the range between 72 and 73 cents, behind the 81-cent average estimate by analysts surveyed by Refinitiv. While profit missed expectations, Salesforce raised its guidance for revenue to the range between $7.22 billion and $7.23 billion, which is in line with estimates. Revenue is expected to increase 24% helped by $285 million from Slack’s sales.

Atlantic Equities analyst believes that the forecast is a reflection of “management conservatism” as Chief Financial Officer Amy Weaver did warn of headwinds to adjusted earnings, along with rising costs that will eat into profits. Management’s guidance continues to incorporate expense seasonality in the undergoing quarter. Increased costs are due to appear in various ways, including investments in the  workforce and growth opportunities, along with travel and expense expectations that are going to cause a quarter over quarter decline in operating margin.

Full year guidance

Just like when it reported its first and second quarter results, Salesforce again raised its full-year expectations. Full-year revenue is expected to be in the range between $26.39 billion and $26.4 billion with adjusted earnings being in the range between $4.68 to $4.69 a share, up from prior projections of $4.36 to $4.38 a share on sales of $26.25 billion to $26.35 billion.

Team news

The company announced the promotion of Bret Taylor, president and COO, to co-CEO. Taylor, who was heavily involved in the acquisition of Slack, will be joining Marc Benioff at the helm. On Monday, Taylor was also announced as the new board chairman of Twitter Inc. (NYSE: TWTR) whose CEO, Jack Dorsey, will be replaced by CTO Parag Agrawal. Salesforce also announced that Williams-Sonoma Inc. (NYSE: WSM) CEO Laura Alber and former United Airlines Holdings Inc. (NYSE: UAL) CEO Oscar Munoz will be joining the company’s board. Alber’s appointment took effect immediately, while Munoz will be taking his seat at the beginning of next year.

Better-than-expected Q3 overshadowed by Omicron

During its September Dreamforce conference, Salesforce showed off how it plans to integrate Slack with other large acquisitions, such as MuleSoft and Tableau, as well as its different verticals focused on specific industries, giving the company plenty of room to room. These prospects indeed gave the company’s shares a boost around Dreamforce time but they have fallen back in recent weeks after hitting record highs in early November.

All in all, better-than-expected third-quarter results were overshadowed by disappointing earnings guidance amid growing concerns surrounding the heavily mutated Covid variant. on Wednesday, the US confirmed its first case in California.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact:

Continue Reading


News From Microsoft’s Soon-To-Be-Metaverse



On Tuesday’s annual general meeting, shareholders voted for Microsoft Inc (NASDAQ: MSFT) to publish a report on the effectiveness of its workplace sexual harassment policies in what was a rare win for activists two decades after the board’s investigation into co-founder Bill Gates’ activities. The board’s recommendation was to reject the proposal, but it ended up being supported by 77.97% votes, as shown by a regulatory filing.

To protect its reputation and shareholder value, Microsoft made an effort with the rise of the MeToo movement with some employees speaking out about experiencing harassment at the company but activists believe the tech titan hasn’t done enough. The software and hardware maker will now need to provide details of its investigations, including that of Gates, as well as the number of cases it has looked into and their outcome.  .

A first step into the metaverse

Microsoft is also taking on Facebook that has now been renamed Meta Platforms Inc (NASDAQ: FB) by bringing its own version of the metaverse to office life.
The US software giant said that in the first half of next year, Teams users would be able to appear as avatars, or animated cartoons in other words. Besides attending virtual meetings, remote workers will also be able to use their avatars to visit their virtual offices. Microsoft’s first step in the new digital universe might seem modest compared to the ambitious vision that Facebook laid out but management sees the adoption of personal avatars as the first step for workers to become comfortable with new forms of virtual interaction.

With 250 million people around the world using Teams, the introduction of avatars is the first element of the metaverse that will make the story real, according to Jared Spataro, the head of the software app. With the help of AI, aavatar’s lips will appear to mouth the words being spoken. Facial expressions and hand gestures will also be in the picture.

Microsoft’s plan is on Mesh technology it unveiled earlier this year to handle complex virtual interactions using PCs to VR headsets.

Following on Musk’s footsteps

Like CEO of Tesla Inc (NASDAQ: TSLA), Microsoft’s chairman and CEO Satya Nadella has shed more than half of shares of the company he’s running. According to a SEC filing, Nadella sold 840,000 Microsoft shares just before Thanksgiving, with proceeds amounting to $285 million. Microsoft has been having a fantastic year with its rock skyrocketing more 50% with the only Dow Jones stock doing better being Home Depot (NYSE: HD).

The tech titan even overpassed Apple (NASDAQ: AAPL) in value with Nadella at the helm so it is only natural that he has been well compensated for his successful leadership. This fiscal year alone, his salary amounted to $2.5 million along with his total annual compensation package, which includes stock awards and cash incentives, that add up to nearly $50 million. Over the past two fiscal years, Nadella earned more than $40 million. Nadella still owns more than 830,000 shares which is  significantly greater than the requirements set by the company’s Board of Directors.

Microsoft is having a great earnings and revenue run thanks to the cloud leadership position Nadella helped it gain since he took over as CEO in 2014. The company’s exceeded $2.5 trillion as it fueled up its Azure cloud unit while core Office 365 suite, LinkedIn corporate social networking unit and Xbox gaming division continue doing a great job at bringing in revenue. Microsoft is knocking on the door of $3 trillion market cap club as it builds its own metaverse and hopefully, a more transparent and accountable company culture.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact:

Continue Reading



Submit an Article

Send us your details and the subject of your article and an IAM editor will be in touch with you shortly