RESEARCH TRIANGLE PARK, N.C., July 13, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the China National Medical Products Administration (NMPA) has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1 Therapeutics. COSELA is now indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for extensive-stage small cell lung cancer. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156M in total milestones. G1 may also receive double-digit royalties on annual net sales of COSELA in China.
"G1 congratulates our partner Simcere on rapidly progressing the development of COSELA in Greater China and successfully obtaining marketing approval from the National Medical Products Administration,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “China is one of the largest markets globally and there remains a great unmet medical need for an effective solution to prevent or reduce the debilitating myelosuppressive side effects of chemotherapy. We are excited Simcere will now be able to make COSELA available to ES-SCLC patients in Greater China, which represents a critical initial milestone in our mission of improving the lives of those impacted by cancer globally."
It is predicted that, by 2040, the number of new cancer patients requiring chemotherapy in China will reach 4.2 million. While chemotherapy remains the cornerstone of treatment for many cancer types, its toxic side effects have widespread impact on patients and can lead to dose reductions or delays, both of which diminish its therapeutic effect. According to Chinese statistics, myelosuppression is associated with more than 80% of chemotherapy drugs. G1 has partnered with Simcere to jointly conduct clinical trials of trilaciclib in colorectal cancer and triple negative breast cancer.
About COSELA® (trilaciclib) for Injection
This is intended for U.S. audiences.
COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.
Indication COSELA® (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Important Safety Information COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the potential for COSELA to change the chemotherapy experience for appropriate patients in China who are battling ES-SCLC and the projected number of cancer patients in China. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Will Roberts Vice President, Investor Relations & Corporate Communications 919-907-1944 wroberts@g1therapeutics.com
Rebecca Levine Director, Corporate Communications and Public Relations (919) 667-8711 rlevine@g1therapeutics.com
(Reuters) -The judge overseeing Twitter Inc's $44 billion lawsuit against Elon Musk has a no-nonsense reputation as well as the distinction of being one of the few jurists who has ever ordered a reluctant buyer to close a U.S. corporate merger. Kathaleen McCormick took over the role of chancellor or chief judge of the Court of Chancery last year, the first woman in that role. On Wednesday, she was assigned the Twitter lawsuit which seeks to force Musk to complete his deal for the social media platform, which promises to be one of the biggest legal showdowns in years.
Rogers knows how to survive — and thrive — in turbulent times.
Alphabet (NASDAQ: GOOGL) (NASDAQ: GOOG) is joining its tech peers in a stock split. The trillion-dollar tech giant, which is the parent company of Google, plans to do a 20:1 stock split on Friday, July 15. If you're aiming to buy Alphabet before the stock split, the clock is ticking.
Intel ( ) is the bearer of additional bad news. The chip giant will give an extra blow to consumers and businesses concerned about the health of the economy. For several weeks in fact, consumers have seen their bills for groceries and other products increase.
The West Virginia senator retracts his support of clean energy provisions in the Democrats' economic package.
Mining stocks could capitulate given waning demand for industrial metals
For nearly six decades, Berkshire Hathaway (NYSE: BRK.A)(NYSE: BRK.B) CEO Warren Buffett has stood head and shoulders above most money managers. Since taking the reins of Berkshire in 1965, Buffett has overseen the creation of more than $610 billion in value for shareholders, as well as led the company's Class A shares (BRK.A) to an aggregate return in excess of 3,600,000%. Given the Oracle of Omaha's incredible track record, investors tend to pay close attention to what he and his investing team are buying and selling.
Yahoo Finance Live examines several of today's trending stocks, including China's tech crackdowns on Alibaba for private data hacks and the outlook for cannabis stocks as American and German lawmakers on legalization bills.
(Bloomberg) -- Carson Block was on a Delta flight to New York when he felt blood pooling on his seat.Most Read from BloombergIvana Trump, First Wife of Former President, Dies At 73Chinese Homebuyers Across 22 Cities Refuse to Pay MortgagesWall Street Texting Habit Sticks Banks With Rare $1 Billion BillBiden to Leave Mideast With No Immediate Announcement on OilIt’s a tale the famous, filter-free founder of trading firm Muddy Waters Capital launches into to make a point about misdoings among shor
Yahoo Finance's Rachelle Akuffo discusses why Pinterest stock is popping on Thursday.
Citigroup's latest earnings beat means that it could be priced fairly for once
The head of the company now running the former McDonald's Corp chain of restaurants in Russia told RBC TV that producers of French fries are refusing to supply to the country and warned that attempts to increase domestic processing are fraught with difficulties. McDonald's quit Russia after a Western backlash against Moscow's military campaign in Ukraine, which included a barrage of economic sanctions, and sold all the restaurants it owned to a local licensee in May. CEO Oleg Paroev told Reuters the chain had sold almost 120,000 burgers on opening day.
U.S. stocks advanced early Friday as Wall Street attempted to shake off this week’s losses. Sentiment was buoyed by better-than-expected retail sales data and a strong earnings report from Citigroup.
Every investor wants to see his stocks pay off – or he wouldn’t be in the markets. But finding the right investment, the ‘one’ that will bring profits, can sometimes be challenging, especially in today's market conditions. The two simplest courses of action an investor can take to ensure solid returns are based on common sense. The first is to buy low and sell high. That is, find a cheap stock with sound fundamentals and good prospects for growth – and buy in to take advantage of the growth pote
Rosenblatt Securities Senior Research Analyst Barton Crockett joins Yahoo Finance Live to discuss Twitter’s lawsuit against Tesla CEO Elon Musk, the SEC questioning the deal, and the outlook for Twitter and its employees.
Bill Gates has promised to give "virtually all" of his fortune away. Where will it go?
Alphabet stock will undergo a 20-for-1 stock split on July 18. Here's how to trade the stock into the event.
Home sale cancellations soared in June. But why?
Most retired workers depend on multiple streams of income during their retirement. Two of the most common such income streams are Social Security and pensions. If we look at pension vs. Social Security income, we find significant differences. Retired workers … Continue reading → The post Pension vs. Social Security: Key Differences appeared first on SmartAsset Blog.
The excitement of investing in a company that can reverse its fortunes is a big draw for some speculators, so even...