Etwas mehr Klarheit zu Fosun und China, ganz frisch: https://hksar.org/...other-for-pandemic-firms-act-together-on-vaccine
While Fosun Pharma started the Jiangsu trials on one of two BioNTech vaccines, its focus has since shifted to seeking regulatory approval for the second candidate, which is now in phase 3, or final trials, run by Pfizer and enrolling some 44,000 people worldwide.
That phase 3 candidate selected for global trials because it produced fewer side effects than the candidate trialled in Jiangsu could be among the first vaccines approved for use overseas and in China.
If the vaccine is successful, it will be approved in China, Hui said, adding that Fosun Pharma was now in the process of seeking approval to run a clinical trial of that candidate in China.
Pfizers CEO Albert Bourla said last month it would be known by the end of October if that vaccine which uses novel mRNA (messenger ribonucleic acid) technology to provoke an immune response within the body worked. This would make it among the first companies to report results on any of the 10 vaccines in final-stage trials around the world.
Hui is hopeful that if the global data shows that the vaccine is safe and effective it could be approved for use in China within a couple of months of US approval.
Our plan is to run a phase 2 trial and bridge the data from the Chinese subjects with the global data, he said, noting that both data sets would be needed for regulatory approval in China.
So there will be a little time difference between our approval [in China] and the approval overseas
we are actively working with the agencies to try to shorten the difference. (..)
Hui said discussions were still taking place over how many doses from BioNTech facilities would be allocated to the Chinese market if the vaccine won approval. A deal to provide 10 million doses to Hong Kong and Macau from BioNTechs European manufacturing facilities has already been signed.
The two companies were exploring how to ensure sufficient and timely supply to China, including the possibility of jointly established manufacturing in China, Hui said.
Kurzfassung auf Deutsch:
- Fosun orientiert nun auch auf BNT162b2, die derzeit in USA etc. in Phase 3 befindliche Variante, und nicht mehr, wie zunächst, auf BNT162b1. Für dessen Zulassung in China ist dort noch eine Phase 2 erforderlich, danach können die weltweiten Phase 3-Daten dort für den Zulassungsantrag verwendet werden. Der Prozess wird zu einigen Monaten Zeitverzögerung gegenüber den USA (der EU) führen. Die gesonderte Phase 2 wurde offenbar noch nicht genehmigt, aber man arbeite diesbezüglich aktiv mit den Agenturen zusammen. - Die schon nach Hong Kong und Macau verkauften 10 Mio. Dosen sollen von BioNTech kommen. Ansonsten wird noch diskutiert, wie viele der von BioNTech hergestellten Dosen nach China gehen sollen. - Die Möglichkeit, dass BioNTech und Fosun gemeinsam eine Produktion in China aufbauen, wird erkundet ("exploring"). Klingt mir etwas schlafmützig. Scheinbar hat Fosun den Impfstoff anfangs mal so "auf Verdacht" mit aufgenommen, ohne ihm besondere Priorität zu geben (sie haben u.a. einen eigenentwickelten Antikörper-Cocktail, ähnlich dem von Eli Lilly, in der Pipeline, für den sie gerade die Studienzulassung in den USA erhalten haben). Jetzt merken sie, dass der Impfstoff-Zug schon ordentlich Fahrt aufgenommen hat, und versuchen doch noch schnell, aufzuspringen. Die chinesische Zulassung der zusätzlichen Phase 3 war Anfang vorletzter Woche nur noch "eine Frage von Tagen" - daraus sind inzwischen schon knapp 2 Wochen geworden. Mal sehen, wie das weitergeht...
Auch interessant: https://www.nst.com.my/business/2020/10/630055/...as-covid-19-vaccine
"KUALA LUMPUR: Hong Seng Consolidated Bhd (HSC), through subsidiary HS Bio Supplies Sdn Bhd, has entered into a unincorporated consortium agreement with RP Integrated Bhd's unit Royce Pharma Manufacturing Sdn Bhd (RPM). The companies will work together to pursue distributorship and opportunities relating to medicinal drugs and Covid-19 vaccine distributed by Shanghai's Fosun Pharmaceutical Group Co Ltd (Fosun), for Malaysia and Southeast Asia markets. HSC said the parties had been invited to jointly issue a letter of intent to Fosun via HS Bio following positive meetings and discussions with Fosun's representatives. (..) "We believe that once the distributorships are secured, it will be a breakthrough accomplishment for HS Bio and a safety net for Malaysians as it will help us to combat the latest wave of infections with the availability of the vaccine," HSC chairman Datuk Teoh Hai Hin said in a statement today. HS Bio is a medical supplies and healthcare related services supply chain management specialist. RPM is one of the oldest and most established pharmaceutical companies in Malaysia and has been producing and marketing over 100 products that cover the various major lines of drugs. Fosun is a leading healthcare group in China and focuses on pharmaceutical manufacturing and research and development. The company has entered late-stage clinical trials for the mRNA vaccine against coronavirus co-developed with a German Biotech company BioNTech, and a US Pharmaceutical company Pfizer. The vaccine could be available for mass inoculations sometime end of this year or beginning next year, if successful. RPM president and chief executive officer Zainal Ariff Mahmood said even if the company was granted the distributorships, there was still a few steps involved. It has to obtain the relevant product approvals and registrations with National Pharmaceutical Regulatory Agency and thereafter work with Pharmaniaga Bhd and the authorities in the proper dissemination of the vaccine." Offenbar will ein malaysisches Konsortium BioNTechs Impfstoff via Fosun beziehen und dann in Malaysia auf eigene Rechnung vermarkten. Könnte - ganz abgesehen von der noch fehlenden Genehmigung der malaysischen Behörden - auch einen kleinen Lizenzstreit zwischen Pfizer und Fosun verursachen. Ich glaube, ganz so wie von dem malaysischen Konsortium geplant, wird das nicht gehen. Zeigt aber dennoch, wie BioNTech nun auch in Südostasien in den Fokus rückt, und verdeutlicht die offensichtliche Neubewertung des Impfstoffs innerhalb von Fosun. |