China’s BeiGene gets nod from FDA for lymphoma med; significance extends further than just a win for one Chinese biotech.

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The News:

The US Food and Drug Administration has given the green light to market a blood cancer drug from Beijing-based BeiGene Ltd., paving the way for American patients to access a Chinese cancer therapy for the first time. The accelerated approval–ahead of even China’s own national drug regulator–marks a breakthrough for the growing legion of Chinese biotech companies determined to take on the world’s biggest pharmaceutical companies in medical innovation and scientific research.

“This means we are not only bringing new drugs into China, we are also bringing new drugs from China to the whole world,” said BeiGene President Wu Xiaobin on Friday in Beijing. “Chinese biotech is on the rise. The industry is not yet on top of the world but we are quickly closing the gap.”

Bloomberg reported that BeiGene’s Brukinsa capsules were approved for patients with mantle cell lymphoma (MCL) that have already received other therapies, and will be a competitor to similar blood cancer therapies from AbbVie Inc. (North Chicago) and AstraZeneca PLC (London).

Investment into Chinese biotech startups is surging as the opening up of the Asian giant’s $132 billion pharmaceutical market creates an unprecedented profit-making opportunity for healthcare companies. The week prior, AstraZeneca announced a $1 billion fund with a Chinese investment bank to support local drug research, while Shanghai-based Green Valley Pharmaceutical Co. Ltd. received Chinese regulatory approval for the first new Alzheimer’s drug in 17 years. BeiGene has emerged as one of the most promising Chinese biotech companies and the new drug, also known as zanubrutinib, is the first in a raft of cancer drugs it is readying for regulatory approval.

In a vote of confidence in its pipeline, American drug giant Amgen Inc. (Thousand Oaks CA) bought a 20.5% stake in BeiGene earlier this month for $2.7 billion to jointly develop cancer therapies. BeiGene said it expects to see another one of its cancer drugs, Tislelizumab, approved by the Chinese regulator by the end of this year. It has not yet disclosed pricing details for Brukinsa. BeiGene’s New York-listed shares closed the week of Nov. 11 off 0.60% at $198.25.

Steve’s Take:

With its Brukinsa approval last Thursday, BeiGene chalked up a couple of firsts: Its own first FDA green light and the first FDA nod for a cancer drug discovered in China; and both came months ahead of schedule.

The new BTK inhibitor, also known as zanubrutinib, grabbed  accelerated approval in previously treated adults with MCL. With plans to launch Brukinsa in the coming weeks, BeiGene will be squaring off against AbbVie and Johnson & Johnson’s first-to-market blockbuster Imbruvica and AstraZeneca’s up-and-coming Calquence. And the Chinese biotech hopes it can come out a winner. BeiGene is pricing Brukinsa at the wholesale acquisition price of $12,935 for a 30-day supply, a company spokesperson told FiercePharma. That’s quite comparable to Imbruvica tablets’ current pricetag but below Calquence’s roughly $14,000.

The FDA’s decision is largely based on tumor shrinkage data from a phase 2 trial in 86 Chinese patients. In that single-arm study, Brukinsa triggered an overall response rate of 84% with a median duration of response of 19.5 months. Some 59% of patients saw a complete response, meaning their cancers were undetectable after treatment. Brukinsa’s numbers “appear compelling relative to Imbruvica (66% ORR, 17% CR) and Calquence (81% ORR, 40% CR),” SVB Leerink analyst Andrew Berens noted. However, cross-trial comparisons can be tricky as patient profiles–such as stages of disease–and trial designs can differ.

Hints could come later this year from the Phase 3 Aspen trial, which pits Brukinsa against Imbruvica in Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma (NHL). That data release is now considered “the largest binary event in our targeted oncology universe,” SVB Leerink analysts said.

While WM is a small indication, the Aspen trial could provide “confirmation that zanubrutinib is a differentiated BTK drug able to compete on a global level,” Berens said in a November note.

As Berens sees it, “the safety and tolerability profile are as important as the efficacy data, as the Achilles heel for Imbruvica is not the lack of efficacy, but the relatively high rates of atrial fibrillation and major hemorrhage,” he said in an October preview of Aspen.

Brukinsa’s current label states that grade 3 or higher bleeding events showed up in 2% of patients treated with the drug, and atrial fibrillation and atrial flutter have occurred in 2% of patients. In comparison, Imbruvica’s label shows 4% for both adverse events.

The Brukinsa nod also bears other significance beyond the drug itself, Berens said in a Friday note to clients.

It “provides validation of the pathway for drug approval based primarily on data generated from China,” he said.

For BeiGene specifically, the approval suggests the company could speed US filing of its PD-1 drug tislelizumab based on China data in non-small cell lung cancer. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, has previously indicated that the agency is willing to consider PD-1 inhibitors based solely on data generated in China.

Besides being a drug development company, BeiGene has served as the Chinese marketing arm of New Jersey-based Celgene Corp., selling Revlimid (lenalidomide), Abraxane (paclitaxel) and Vidaza (azacitidine). Product sales and collaboration income has accounted for $371 million in revenue this year, but because of its expansive R&D work it has recorded a $561 million loss through the first nine months. The opportunity to become an in-country partner for big biopharma has grown. Amgen recently signed a deal for BeiGene to market up to 23 drugs in China.

Bottom Line:

BeiGene has gone through an momentous year so far. First, its founder and chief exec John Oyler’s robust 2018 pay package of $27.9 million wrinkled some foreheads among investors. After Opdivo developer Bristol-Myers Squibb Co. unveiled its $74 billion acquisition of BeiGene’s PD-1 partner Celgene, the Chinese biotech is now developing tislelizumab on its own. Then, it fended off a US-based short-seller’s accusation that the company had faked sales figures in China.

BeiGene’s approval for Brukinsa is a breakthrough for pioneering Chinese biopharma developers, which are setting their sights on Western markets, even as Western Big Pharma seeks to expand into China. While trade clashes between the US and China roil stock markets, the pharmaceutical players in both countries sit back and watch their revenues and shares continue to climb higher. This cross-global gold rush isn’t a trend likely to wane anytime soon. Unless the US and China suddenly morph into Russia; well, figuratively speaking.

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