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It’s breathtaking’: A Chinese biotech CEO weighs in on policy changes remaking China’s FDA

STAT

Biotech

It’s breathtaking’: A Chinese biotech CEO weighs in on policy changes remaking China’s FDA

By Rebecca Robbins @rebeccadrobbins

https://www.statnews.com/2018/02/22/james-xue-biotech-ceo-china-fda/

February 22, 2018

With China’s biotech sector on the rise, changes are afoot at the agency tasked with regulating the country’s pipeline of new drugs.

In recent months, China’s version of the U.S. Food and Drug Administration, known as CFDA, has introduced a host of new regulations meant to make drug makers happy: Companies can now submit certain datafrom clinical trial sites outside of China. More Chinese hospitals can run trials. Manufacturing need no longer be done in-house. And drug makers weary of waiting for a green light to proceed with a safety study could soon be allowed to go ahead if they don’t hear back from the agency within 60 days.

James Xue, CEO of Beijing-based CANbridge Life Sciences, has had a front-row view of it all. He’s been interacting with CFDA officials on and off for the past 15 years, first in running Genzyme’s China operations and now in steering his own biotech company seeking approval for four oncology drugs. And Xue knows how drug approval works in the U.S., too: Born and raised in China, Xue did his graduate education and started his biopharma career in the U.S. before coming home as part of Thousand Talents, a Chinese government recruitment program that’s seen both successes and struggles.

So what does the raft of changes at the CFDA look like to such a tuned-in observer? We called up Xue to get his impressions.

What do you make of all these changes at the CFDA?

“In the last 12 months, I have experienced more reform and drastic change for better [than] over the 14 years before that combined,” Xue said. “It’s breathtaking, in a very good, very positive way.”

James Xue, CEO of CANbridge Life Sciences CANbridge Life Sciences

The palpable change, he says, extends to how quickly CFDA officials respond in correspondence about his company’s applications — a change he attributes to the agency’s moves to cut the backlog of applications for old generic products.

What’s the biggest difference between working with China’s FDA and the U.S. FDA?

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“The biggest difference prior to the reforms last year was the mentality,” Xue said. The CFDA was “not really risk taking at all.”

But the recent changes at the CFDA are making it not so different to work with drug regulators in China compared to those in the U.S., Xue said.

How have changes at the CFDA shaped your strategy at CANbridge?

Of the four drugs CANbridge is trying to get approved in China, two have already been approved in other countries. For the other two molecules, Xue is going to China for first-time approval.

Now that his team can submit data from clinical trial sites outside of China, Xue is taking a second look at the data from global clinical trials supporting several of the molecules his company has licensed to try to commericalize in China. “Before, we had to reproduce those data,” he said.

That same change has Xue thinking more about future hiring plans in North America. And another recent policy change allowed him to open a clinical trial site in Taiwan in pursuit of an approval in China.

Have any of the recent changes at the CFDA made it harder for you to do business or move your products along swiftly?

Xue pointed to a new CFDA policy that allows drug makers to contract out their manufacturing to a plant in China, instead of having to set up a plant in-house. That’s a “very positive” change, Xue said, but it doesn’t go far enough. He’d like to see it extend to manufacturing plants outside of China.

“I wish the CFDA would be more bold in allowing ex-China manufactured product to be entitled to the same benefits of the reform,” Xue said. That way, “we would not need to duplicate efforts by transporting a manufacturing process that is already very matured and established in the West for the sake of bypassing this laborious process.”

What challenges remain in working with the CFDA?

“I think the biggest pain point is still the truly innovative drug categories,” Xue said. When it comes to cutting-edge science, “the Chinese FDA is still not yet experienced enough to review the protocol or to give constructive input in making the protocol less risky” and more likely to get approved.

When you talk with U.S. biotech CEOs, how aware are they of all these changes at China’s FDA?

“I’m surprised, actually,” Xue said. “Their senior executives are very tuned in to the recent reforms in China. I have no doubt that they affect how they do their corporate strategy on a global basis. Nobody can afford to deprioritize China’s rise.”

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China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

The news source of record covering the development of innovative human therapies

Actionable Intelligence • Incisive Analysis
February 7, 2018 Volume 29, No. 26
http://www.bioworld.com/content/chinas-canbridge-nabs-pumas-nerlynx-her2-breast-cancer-70m-deal-0

China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

By Shannon Ellis, Staff Writer

SHANGHAI – Beijing’s Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.’s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China.

The deal will provide Puma with an up-front payment of $30 million, with the possibility of another $40 million upon regulatory milestones. Royalties and sales milestones could also provide Puma with further payments.

Nerlynx, an irreversible tyrosine kinase inhibitor, was approved by the U.S. FDA in July. But the Los Angeles-based company encountered pushback from Europe’s regulators, with the Committee for Medicinal Products for Human Use (CHMP) indicating a negative trend vote last month. (See BioWorld, July 19, 2017, and Jan. 25, 2018.)

With poor prospects in Europe, Canbridge remains steadfast about Nerlynx’s chances in greater China. “We assessed the opportunity and even with the recent news from Europe, we will not waver in terms of our position to get this product to patients in China,” James Xue, Canbridge chairman, CEO and president, told BioWorld. “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.”

Nerlynx is approved in the U.S. as an adjuvant for patients using Herceptin (trastuzumab, Roche Holding AG)-based therapy with HER2-positive breast cancer. About 20 percent to 25 percent of breast cancer patients overexpress the HER2 protein.

After a course of Herceptin, patients often have no additional treatment options, explained Xue. Depending on the individual, within about five years a significant number of patients – up to 25 percent – will find the cancer recurs in a very vicious form. Many patients lacking treatment options will die within six months; Xue called it “a very dire situation.” In China, that is especially so. “In terms of Chinese patients, the Chinese breast cancers are more aggressive compared to the western form and occur in a younger age group relative to the western patient population,” said Xue.

Assessing the global phase III MRCT data from Puma, Xue said a significant number of patients taking Nerlynx had reduced rates of recurring cancer vs. the comparator (according to Puma’s release it can be 34 percent). “This is a major accomplishment and clinical benefit for patients who do not have recurring cancer; they will live over five years,” Xue said. “And for those with recurring cancer, it allows those patients to have a chance at extended disease-free survival.”
Accelerated approval in China possible
This enhanced blood flow effects of viagra more info here results in healthy, long and thick erections. Sildenafil may be brought with or without nourishment, yet bringing it with a high-fat supper may build the time before buy viagra without prescription the solution begins working. The amalgamation of this generic medicine and the sexual organ. tadalafil vs cialis Oil massaging of genital organ helps in dilating blood vessels and improving the circulation of blood. viagra for sale The large amount of data that Puma collected in its global pivotal study may help Canbridge seek accelerated approval in China. Post-ICH (International Council for Harmonisation) admittance, China’s regulators have said they will accept global data. Since a portion of the data collected by Puma also included Chinese patients and those of Asian ethnicity, there is a chance that Canbridge may be able to seek approval without a clinical study in China, or only a limited one.

“We believe that we will be able to leverage the existing data to a maximum extent for a shortened market approval pathway,” said Xue. “We will leverage the data that Puma has already built on a global scale, including Asian patients with their pivotal study. Over 2,000 patients enrolled in the pivotal study over five years – it is one of the most sophisticated studies ever done in breast cancer.”

But in Europe, regulators have raised concerns over the clinical relevance and risk-worthiness of Nerlynx in extended adjuvant use for women with early stage, HER2-positive breast cancer and asked for Puma to take “additional steps.”

Puma said the CHMP found a benefit-risk assessment for Nerlynx to be negative since it was based solely on evidence from a single pivotal trial and because “two- and five-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.”

Another factor Canbridge will need to work through when discussing Nerlynx with Asian regulators are the side effects of Nerlynx, including grade III diarrhea. “Puma did a good job to educate us about how they developed effective patient management protocol for the side effects,” Xue said. “We looked at the data for the prevalence and seriousness of the diarrhea … the protocol developed by Puma should be very straightforward for us to adopt in China.”

Meanwhile, in the U.S., Puma is seeking to widen the scope of use for Nerlynx to more HER2-expressed cancers in a basket trial for patients with breast, cervical, biliary, salivary and non-small-cell lung cancers.

Canbridge will take the lead on gastric cancer, which is highly prevalent in China. The company will also seek out approval for other forms of HER2-positive cancers as well, including late-stage metastatic breast cancer in China.

Getting market ready
With many of China’s regulatory hurdles now lowered, Canbridge, like many Chinese biotech startups, is getting market ready for the first time. The firm’s plan is to see Nerlynx on the market by mid-2019. In advance of that, Canbridge’s CAN-002 for mucositis caused by radiation or high-dose chemotherapy should receive CFDA approval.

“The timing of this deal is excellent in terms of building a full-fledged commercial presence which is already underway,” said Xue. “This is transformative because it accelerates our vision to build a virtually integrated company from development to full commercialization. My team and I are very excited about Puma’s decision to choose us as a partner. We want to be

“I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the au¬thorities in our geographies, including main¬land China, Taiwan, Hong Kong and Macau.
James Xue
Chairman, President/CEO, Canbridge

known as the partner of choice in China and greater Asia area for such opportunities.”

The remainder of Canbridge’s pipeline is more early stage. CAN- 008 for glioblastoma multiforme is already in phase I trials in Taiwan. The biotech holds the greater China rights for CAN-008, which has been designated a MAH (marketing authorization holder) pilot project in China where it is seeking an IND. In addition, Canbridge’s CAN-017 is also seeking an IND in China for squamous cell esophageal cancer. Canbridge holds global rights for CAN-017, excluding North America. ,

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China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

BioWorld

The news source of record covering the development of innovative human therapies

Actionable Intelligence • Incisive Analysis

February 7, 2018 Volume 29, No. 26

http://www.bioworld.com/content/chinas-canbridge-nabs-pumas-nerlynx-her2-breast-cancer-70m-deal-0

or click here for a PDF version BioWorld 2

China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

By Shannon Ellis, Staff Writer

SHANGHAI – Beijing’s Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.’s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China.

The deal will provide Puma with an up-front payment of $30 million, with the possibility of another $40 million upon regulatory milestones. Royalties and sales milestones could also provide Puma with further payments.

Nerlynx, an irreversible tyrosine kinase inhibitor, was approved by the U.S. FDA in July. But the Los Angeles-based company encountered pushback from Europe’s regulators, with the Committee for Medicinal Products for Human Use (CHMP) indicating a negative trend vote last month. (See BioWorld, July 19, 2017, and Jan. 25, 2018.)

With poor prospects in Europe, Canbridge remains steadfast about Nerlynx’s chances in greater China. “We assessed the opportunity and even with the recent news from Europe, we will not waver in terms of our position to get this product to patients in China,” James Xue, Canbridge chairman, CEO and president, told BioWorld. “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.”

Nerlynx is approved in the U.S. as an adjuvant for patients using Herceptin (trastuzumab, Roche Holding AG)-based therapy with HER2-positive breast cancer. About 20 percent to 25 percent of breast cancer patients overexpress the HER2 protein.

After a course of Herceptin, patients often have no additional treatment options, explained Xue. Depending on the individual, within about five years a significant number of patients – up to 25 percent – will find the cancer recurs in a very vicious form. Many patients lacking treatment options will die within six months; Xue called it “a very dire situation.” In China, that is especially so. “In terms of Chinese patients, the Chinese breast cancers are more aggressive compared to the western form and occur in a younger age group relative to the western patient population,” said Xue.

Assessing the global phase III MRCT data from Puma, Xue said a significant number of patients taking Nerlynx had reduced rates of recurring cancer vs. the comparator (according to Puma’s release it can be 34 percent). “This is a major accomplishment and clinical benefit for patients who do not have recurring cancer; they will live over five years,” Xue said. “And for those with recurring cancer, it allows those patients to have a chance at extended disease-free survival.”

Accelerated approval in China possible
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The large amount of data that Puma collected in its global pivotal study may help Canbridge seek accelerated approval in China. Post-ICH (International Council for Harmonisation) admittance, China’s regulators have said they will accept global data. Since a portion of the data collected by Puma also included Chinese patients and those of Asian ethnicity, there is a chance that Canbridge may be able to seek approval without a clinical study in China, or only a limited one.

“We believe that we will be able to leverage the existing data to a maximum extent for a shortened market approval pathway,” said Xue. “We will leverage the data that Puma has already built on a global scale, including Asian patients with their pivotal study. Over 2,000 patients enrolled in the pivotal study over five years – it is one of the most sophisticated studies ever done in breast cancer.”

But in Europe, regulators have raised concerns over the clinical relevance and risk-worthiness of Nerlynx in extended adjuvant use for women with early stage, HER2-positive breast cancer and asked for Puma to take “additional steps.”

Puma said the CHMP found a benefit-risk assessment for Nerlynx to be negative since it was based solely on evidence from a single pivotal trial and because “two- and five-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.”

Another factor Canbridge will need to work through when discussing Nerlynx with Asian regulators are the side effects of Nerlynx, including grade III diarrhea. “Puma did a good job to educate us about how they developed effective patient management protocol for the side effects,” Xue said. “We looked at the data for the prevalence and seriousness of the diarrhea … the protocol developed by Puma should be very straightforward for us to adopt in China.”

Meanwhile, in the U.S., Puma is seeking to widen the scope of use for Nerlynx to more HER2-expressed cancers in a basket trial for patients with breast, cervical, biliary, salivary and non-small-cell lung cancers.

Canbridge will take the lead on gastric cancer, which is highly prevalent in China. The company will also seek out approval for other forms of HER2-positive cancers as well, including late-stage metastatic breast cancer in China.

Getting market ready

With many of China’s regulatory hurdles now lowered, Canbridge, like many Chinese biotech startups, is getting market ready for the first time. The firm’s plan is to see Nerlynx on the market by mid-2019. In advance of that, Canbridge’s CAN-002 for mucositis caused by radiation or high-dose chemotherapy should receive CFDA approval.

“The timing of this deal is excellent in terms of building a full-fledged commercial presence which is already underway,” said Xue. “This is transformative because it accelerates our vision to build a virtually integrated company from development to full commercialization. My team and I are very excited about Puma’s decision to choose us as a partner. We want to be

 “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the au­thorities in our geographies, including main­land China, Taiwan, Hong Kong and Macau.

James Xue

Chairman, President/CEO, Canbridge

known as the partner of choice in China and greater Asia area for such opportunities.”

The remainder of Canbridge’s pipeline is more early stage. CAN- 008 for glioblastoma multiforme is already in phase I trials in Taiwan. The biotech holds the greater China rights for CAN-008, which has been designated a MAH (marketing authorization holder) pilot project in China where it is seeking an IND. In addition, Canbridge’s CAN-017 is also seeking an IND in China for squamous cell esophageal cancer. Canbridge holds global rights for CAN-017, excluding North America.