Xbrane Biopharma – kinesiska marknadens potential

Informativ läsning om den kinesiska marknaden för biosimilars och dess potential. Eftersom Kina verkar sakna “formal set of regulatory guidelines around the approval or manufacturing of biosimilars” till skillnad från t ex USA och EU, och har en enorm marknad, kan Xbrane förmodligen bli en riktig framgång.

Artikel 1

http://www.biopharmadive.com/news/best-of-bd-biosimilars-in-china-the-coming-revolution/324525/

It seems that the entire world is working towards a framework for developing and approving biosimilars, as demand grows for access to biologics at lower prices. But what about China—a $75 billion pharmaceutical market (ranked 3rd after the U.S. and Japan)—that is growing at a compounded annual rate of 25%?

 
China, too, is embracing biosimilars, with three approved products being sold in the Chinese market and several high-profile Chinese biotech companies building GMP-certified manufacturing facilities for biosimilar production.

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In China, there is no formal set of regulatory guidelines around the approval or manufacturing of biosimilars. In fact, with respect to regulatory overisight, biosimilars are treated more like novel biologics. That’s what’s led some industry experts like Greg Scott, founder and president of consulting firm ChinaBio LLC, to suggest that the copycat biologics that are approved in China aren’t biosimilars at all—they’re follow-on biologics.

Artikel 2 (Xbranes prospekt) 

http://xbrane.com/app/media/2016/01/Xbrane-Prospekt.pdf

 
Tillverkningen av biosimilarer är i jämförelse med generika på syntetiskt tillverkade småmolekylsläkemedel mer komplex på grund av  de naturliga variationerna  mellan  levande celler samt svårigheten i att exakt replikera produktionsprocessen och strukturen för originalläkemedlet. Flertalet regulatoriska myndigheter har därför introducerat en specifik regulatorisk process för godkännande av dessa. De kallas under denna regulatoriska process för biosimilarer, det vill säga liknande men inte exakta kopior av originalläkemedlen. Kraven  för marknadssgodkännande är därmed mer omfattande än för vanlig generika då något större jämförandestudier krävs. Det är dock inte ovanligt att godkännandeprocessen för biosimilarer i tillväxtländer (också Kina, min kommentar) sammanfaller med den för sedvanligt generikaläkemedel, varefter de i förekommande fall istället benämns som biogenerika.

Artikel 3

https://www.cphi.com/china/visit/news-and-updates/biosimilars-global-markets

 
Where does China stand?
In 2014, the draft on biosimilar guidelines was issued.Once a clear regulatory pathway for biosimilars is established, the market will be very attractive not only due to the volume potential but also the growing ability to pay.

 
Similar to the tight controls requiring international companies to create partnerships or use domestic pharmaceutical distributors, the successful manufacturing and marketing of biosimilars will also require partnerships with domestic companies.

IN ENGLISH

Xbrane Biopharma – Chinese market potential

​Informative reading about the Chinese market for biosimilars and its potential. Since China seems to be missing “formal set of regulatory guidelines around the approval of manufacturing biosimilars”, unlike the United States and the EU, and has a huge market, Xbrane can probably be a real success.

Article 1

http://www.biopharmadive.com/news/best-of-bd-biosimilars-in-china-the-coming-revolution/324525/

 
It seems that the entire world is working towards a framework for developing and approving biosimilars, as demand grows for access to biologics at lower prices. But what about China—a $75 billion pharmaceutical market (ranked 3rd after the U.S. and Japan)—that is growing at a compounded annual rate of 25%?
China, too, is embracing biosimilars, with three approved products being sold in the Chinese market and several high-profile Chinese biotech companies building GMP-certified manufacturing facilities for biosimilar production.

———————————

In China, there is no formal set of regulatory guidelines around the approval or manufacturing of biosimilars. In fact, with respect to regulatory overisight, biosimilars are treated more like novel biologics. That’s what’s led some industry experts like Greg Scott, founder and president of consulting firm ChinaBio LLC, to suggest that the copycat biologics that are approved in China aren’t biosimilars at all—they’re follow-on biologics.

Article 2 (Xbrane prospectus)

http://xbrane.com/app/media/2016/01/Xbrane-Prospekt.pdf

The production of biosimilars is more complex due to the natural variations between living cells and the difficulty of accurately replicating the production process and the structure of the original drug compared with the genes of synthetically manufactured small molecule drugs. The majority of regulatory authorities have therefore introduced a specific regulatory process for the approval of these. They are under this regulatory process named biosimilars, ie similar but not exact copies of the original drugs. The requirements for market approval are therefore more extensive than for normal generics because somewhat more coprehensive comparative studies are required. However, it is not uncommon that the approval process for biosimilars in emerging countries (including China) coincides with that of conventional generic drugs, whereafter they are instead referred to as biogenerics instead.

Article 3

https://www.cphi.com/china/visit/news-and-updates/biosimilars-global-markets

Where does China stand?

In 2014, the draft on biosimilar guidelines was issued. Once a clear regulatory pathway for biosimilars is established, the market will be very attractive not only due to the volume potential but also the growing ability to pay.

Similar to the tight controls requiring international companies to create partnerships or use domestic pharmaceutical distributors, the successful manufacturing and  marketing of biosimilars will also require partnerships with domestic companies.

Tänkvärt inför avgörandet

Tiden är snart inne då aktieägarna får klarhet i huruvida det blir en snabb lösning till APCLs fördel (enda möjligheten till en snabb lösning är ju att Gambia och APCL kommer överens om en förlängning eller att APCL går in i nästa fas av licenserna) eller om den juridiska processen initieras.

Även om APCL initierar en juridisk process betyder inte det att vi står inför en uttdragen process. Detta är inte min egen tolkning utan det baseras på fakta, bland annat med referens till den förra liknande juridiska dispyten gällande samma licenser i just Gambia (https://www.clydeco.com/firm/news/view/clyde-co-advises-african-petroleum-in-successful-outcome-to-icsid-proceedin)

Vi vet också att en eventuell juridisk process kommer att hanteras av the International Centre for Settlement of Investment Disputes (ICSID). Gambia har ratificerat den bindande konventionen. Således kommer rättsprocessen att hanteras av ICSID och följa the ICSID arbitral rules. Gambia har tidigare varit involverade i ett flertal dispyter gällande bland annat oljeutvinning och inom mining, varav en dispyt alltså var mot just APCL och samma licenser som är föremål för eventuell dispyt just nu. Utgången av den förra dispyten med APCL refererar jag till ovan.

https://icsid.worldbank.org/en/Documents/icsiddocs/List%20of%20Contracting%20States%20and%20Other%20Signatories%20of%20the%20Convention%20-%20Latest.pdf

Jag avslutar med att återge African Petroleums pressrelease från den 21 augusti 2017.

The Company confirms that it is yet to receive any formal feedback from the Gambian authorities regarding the status of its A1 and A4 licences.

The management notes the rhetoric in recent local press articles that state the licences have expired and are open acreage. As such, the management feels it appropriate to firmly reiterate, once again, that this is misleading and incorrect in both law and fact. African Petroleum has not received formal notification initiating the termination process as detailed in the licences, and therefore retains it’s rights under the A1 and A4 licences.

Whilst the management continues to seek a positive dialogue in the coming weeks, it is currently undertaking the necessary legal preparations to utilise the dispute resolution provisions of the licences in order to protect African Petroleum’s legal rights in relation to the licences and will formally initiate this process in early September unless formal positive feedback is forthcoming by the end of August.

Commenting on the update, CEO Jens Pace said: “It is clearly frustrating to be in a position where we feel it necessary to issue updates to the market on account of unconfirmed local media reports. We were given guidance by the President of The Gambia that formal feedback would be provided to the Company following cabinet level discussions and so we remain hopeful that this will be forthcoming. I reassure our shareholders that we, after taking external legal advice, are very confident of our legal position in terms of these licences. We are therefore taking the appropriate measures to ensure we move swiftly to protect our rights on these licences should we not receive formal feedback by the end of the month, or should that feedback not be in line with our expectations.”