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Post by mnholdem on Oct 13, 2017 9:28:40 GMT -5
As part of the renegotiated purchase agreement with MannKind, Amphastar Pharmaceuticals (who supply the insulin used in Afrezza) secured first rights of refusal for any deals involving sales in China. Amphastar already has a manufacturing plant (Amphastar Nanjing Pharmaceuticals) in Nanjing, China. This may serve to expedite approval for a couple reasons.
First, Amphastar has experience with the Chinese regulatory pathway. Second, China usually insists that products sold in China are also manufactured in China. ANP doesn't manufacture insulin at their Nanjing plant, but they could set up finish fill lines there because of differing packaging for the Chinese market.
The approval process may still take over a year but the other factor involved is simply that Afrezza uses insulin (human), and active pharmaceutical ingredient (API) which has been sold in the market for decades.
Finally, there is the well-documented needle-phobia population in China. The Chinese regulatory agency may consider all of these things when deciding whether to expedite approval.
I think the review may still take over a year, but the reward is worth the wait, IMO.
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Post by invn00b on Oct 13, 2017 9:47:28 GMT -5
As part of the renegotiated purchase agreement with MannKind, Amphastar Pharmaceuticals (who supply the insulin used in Afrezza) secured first rights of refusal for any deals involving sales in China. Amphastar already has a manufacturing plant (Amphastar Nanjing Pharmaceuticals) in Nanjing, China. This may serve to expedite approval for a couple reasons.
First, Amphastar has experience with the Chinese regulatory pathway. Second, China usually insists that products sold in China are also manufactured in China. ANP doesn't manufacture insulin at their Nanjing plant, but they could set up finish fill lines there because of differing packaging for the Chinese market.
The approval process may still take over a year but the other factor involved is simply that Afrezza uses insulin (human), and active pharmaceutical ingredient (API) which has been sold in the market for decades.
Finally, there is the well-documented needle-phobia population in China. The Chinese regulatory agency may consider all of these things when deciding whether to expedite approval.
I think the review may still take over a year, but the reward is worth the wait, IMO.
Awesome insight mnholdem, do we know if the API/Insulin used in the manufacture of US market Afrezza comes from Nanjing? If so, this would likely expedite the approval for a number of reasons. Still agree that it would likely take over a year. |
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Post by mnholdem on Oct 13, 2017 10:20:33 GMT -5
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Post by peppy on Oct 13, 2017 10:28:11 GMT -5
As part of the renegotiated purchase agreement with MannKind, Amphastar Pharmaceuticals (who supply the insulin used in Afrezza) secured first rights of refusal for any deals involving sales in China. Amphastar already has a manufacturing plant (Amphastar Nanjing Pharmaceuticals) in Nanjing, China. This may serve to expedite approval for a couple reasons.
First, Amphastar has experience with the Chinese regulatory pathway. Second, China usually insists that products sold in China are also manufactured in China. ANP doesn't manufacture insulin at their Nanjing plant, but they could set up finish fill lines there because of differing packaging for the Chinese market.
The approval process may still take over a year but the other factor involved is simply that Afrezza uses insulin (human), and active pharmaceutical ingredient (API) which has been sold in the market for decades.
Finally, there is the well-documented needle-phobia population in China. The Chinese regulatory agency may consider all of these things when deciding whether to expedite approval.
I think the review may still take over a year, but the reward is worth the wait, IMO.
Awesome insight mnholdem, do we know if the API/Insulin used in the manufacture of US market Afrezza comes from Nanjing? If so, this would likely expedite the approval for a number of reasons. Still agree that it would likely take over a year. you are correct. The insulin MNKD had/has from Pfizer would also need approval for afrezza. "Amphastar manufactures the insulin used in Afrezza from their facility in France."
www.amphastar.com/facilities.html
(we trust no one.)
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Post by barnstormer on Oct 13, 2017 10:36:39 GMT -5
Amphaster is already operating in China, partners with Mannkind and has first right of refusal to distribute Afrezza in China. They may have already files.
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Post by barnstormer on Oct 13, 2017 10:38:23 GMT -5
Sorry holdem, did't get all the way through your post.
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Post by invn00b on Oct 13, 2017 10:48:27 GMT -5
Awesome insight mnholdem, do we know if the API/Insulin used in the manufacture of US market Afrezza comes from Nanjing? If so, this would likely expedite the approval for a number of reasons. Still agree that it would likely take over a year. you are correct. The insulin MNKD had/has from Pfizer would also need approval for afrezza. "Amphastar manufactures the insulin used in Afrezza from their facility in France."
www.amphastar.com/facilities.html
(we trust no one.)
ah, bummer! Having the insulin come from Nanjing could've really greased the regulatory approval gear. If they did want to source from Nanjing for the Chinese market I don't see how CFDA would allow them to bypass all clinical study requirements and leverage existing data, some but not likely all. It will be interesting to see how this plays out. |
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Post by peppy on Oct 13, 2017 11:03:00 GMT -5
you are correct. The insulin MNKD had/has from Pfizer would also need approval for afrezza. "Amphastar manufactures the insulin used in Afrezza from their facility in France."
www.amphastar.com/facilities.html
(we trust no one.)
ah, bummer! Having the insulin come from Nanjing could've really greased the regulatory approval gear. If they did want to source from Nanjing for the Chinese market I don't see how CFDA would allow them to bypass all clinical study requirements and leverage existing data, some but not likely all. It will be interesting to see how this plays out. Being blind is something that seems to have happened to us. 
You are however correct. China had a one child policy for years. What would make us think, the government wants nothing less then survival of the fittest?
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Post by dreamboatcruise on Oct 13, 2017 12:20:14 GMT -5
Speaking of next moves, I wonder if MNKD is now talking to the FDA about a new TV advert to include the pd info. Would patients understand the significance of faster clearance from the body if MNKD is still constrained on what can be said about hypos?
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Post by MnkdWASmyRtrmntPlan on Oct 13, 2017 17:09:56 GMT -5
www.raps.org/Regulatory-Focus/News/2017/10/10/28647/Asia-Regulatory-Roundup-China-Opens-Door-to-Foreign-Trial-Data-for-Accelerated-Approvals-10-October-2017/#Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017) Posted 10 October 2017 By Nick Paul Taylor Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. ... Most notably for multinational drug developers, China is proposing to accept clinical trial data generated overseas, provided the studies comply with relevant requirements. This would free drug developers of the time and expense of running large Chinese clinical trials of products that have already proven their safety and efficacy overseas. The only caveat is companies must cover ethnic differences in their applications. ...
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