FAST NEWS: BeiGene’s Lymphoma Drug Recommended to Enter European Regulator

The latest: BeiGene Ltd. (BGNE.US; 6160.HK; 668235.SH) announced Monday that its Zanubrutinib drug has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which recommended approval for the drug to treat adults with marginal zone lymphoma. Looking up: Following the positive opinion, the European Commission will consider BeiGene’s marketing application, with a final decision expected within 67 days. If approved for marketing, the drug is expected to enter the world’s largest market with 29 member countries. Take Note: Marginal zone…

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Junshi Biosciences Hits Revenue Roadblock Amid Covid Drug Delay

Junshi Biosciences is facing business headwinds. Its key cancer drug has not sold as well as competing products and the company has yet to file a marketing application for its eagerly awaited Covid-19 oral drug. Key Takeaways: The company logged a revenue fall of 55% in the first half of the year and posted a loss of $131 million Phase 3 clinical trials for its Covid-19 oral drug wrapped up in May but the company has still not yet filed an application to market the product   By Molly Wen…

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U.S.-China Audit Deal Won’t Slow Hong Kong Dual Listing Train, Analysts Say

The landmark information-sharing agreement won’t dispel concerns over delistings of Chinese firms from New York until the deal is smoothly implemented Key Takeaways: Despite a landmark U.S.-China information-sharing agreement, some predict dual listings in New York and Hong Kong will remain the preferred choice for Chinese stocks UBS estimates Hong Kong Stock Exchange trading volume could rise up to 25% if all U.S.-traded Chinese stocks delist from New York and move to Hong Kong By Ken Lo The new information-sharing agreement between U.S. and China stock regulators was a welcome…

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InnoCare Revs Up for Next Phase With Strong Results, IPO Plan

Sales of the company’s key Orelabrutinib cancer drug doubled in the first half of the year, contributing to a 142% revenue jump for the period Key Takeaways: InnoCare Pharma’s revenue surged 142% in the first half of the year, but the company still lost money due to soaring R&D expenses and foreign exchange losses The company will use 4 billion yuan from a Shanghai STAR Market IPO to boost production and accelerate its product commercialization By Molly Wen Chinese drug stocks have cooled noticeably in the past year, as investors…

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As Losses Narrow, Is Zai Lab Finally Finding its Winning Formula?

The biotech breaks a cycle of widening losses as it shifts towards developing new drugs Key Takeaways: Zai Lab reported its loss shrank 65% in the first quarter of the year while its revenues continued to rise The company slashed its R&D costs by cutting licensing payments for existing drugs while spending more on finding new remedies By Tina Yip Zai Lab, like many pharma start-ups in China, kickstarted its business by licensing proven drugs from other companies. Investors had high hopes that it would later transform into an innovator…

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Amid Slowing Sales at Home, Innovent Biologics Stumbles Overseas

Cancer drug maker ended a tie-up to bring one of its drugs to North America last week, less than two months after its best-selling product was rejected by the FDA Key takeaways: Innovent Biologics terminated a plan to sell its bevacizumab biosimilar in North America with a local partner after trials for the drug fell behind schedule The company’s loss tripled last year on growing competition for its core product, whose sales fell 22% in this year’s first-quarter By Molly Wen With domestic competition heating up in the crowded China…

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Junshi Biosciences Back in the Red, Pins Hopes on Covid Drugs

The innovative drug developer reported a first-quarter loss as a result of a steep drop in licensing revenue Key Takeaways: Junshi Biosciences’ revenue tumbled 61% in the first quarter, reflecting its high dependence on income from overseas licensing The company is hoping for steadier future revenue from an oral Covid-19 drug now in Phase 3 multi-regional clinical trials (MRCTs) By Molly Wen 2021 was a bittersweet year for Shanghai Junshi Biosciences Co. Ltd. (1877.HK; 688180.SH). Its Covid-19 neutralizing antibody drug JS016 was a hit overseas and became a major new…

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InnoCare Pharma Goes Back to Funding Trough With STAR Market Listing

The Hong Kong-traded company will become the latest from the cash-challenged pharma sector to make a second listing on the A-share market Key Takeaways: InnoCare Pharma’s A-share IPO will make it the fourth innovative pharma company with shares traded in Hong Kong and on the mainland’s STAR Market   The company is flush with cash and continues to raise money at every opportunity to finance its R&D By Molly Wen China’s Nasdaq-style STAR Market has become fertile ground for fundraising by innovative yet profit-challenged pharmaceutical companies since its launch in…

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Cancer Drug Maker BeiGene Takes Action to Mitigate Delisting Risk

Company has changed auditors in a bid to comply with U.S. law and avoid a potential forced delisting from the Nasdaq Key Takeaways: BeiGene has switched auditors for its New York listing to a U.S. company from a Chinese one in a move to comply with U.S. law The change could reduce the company’s threat of being forcibly delisted from the Nasdaq By Doug Young It may have listings in Hong Kong and Shanghai, but cancer drug maker BeiGene Ltd. (BGNE.US; 6160.HK; 668235.SH) is making it clear it wants to…

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FAST NEWS: SEC Names Five Chinese Stocks at Threat of Delisting

The latest: The U.S. Securities and Exchange Commission (SEC) announced Thursday that it has placed five Chinese companies on a list of companies that could face the threat of delisting under the Foreign Company Accountability Act, including BeiGene, Ltd. (BGNE.US; 6160.HK; 688235.SH), Zai Lab Ltd. (ZLAB.US; 9688.HK), Yum China Holdings Inc. (YUMC.US; 9987.HK HK), Hutchmed (China) Ltd. (HCM.US; 0013.HK) and ACM Research Inc. (ACMR:US). Looking up: There are currently more than 270 Chinese stocks listed in the U.S. The SEC has named only five this time, giving the others time…

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