NPRA1985

NPRA1985 | Joined since 2020-09-03

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2020-12-09 15:02 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

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2020-12-09 15:02 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

Stock

2020-12-09 15:01 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

Stock

2020-12-09 15:01 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

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2020-12-09 15:00 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

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2020-12-09 14:59 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

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2020-12-09 14:58 | Report Abuse

UAE’s health ministry officially registers Sinopharm COVID-19 vaccine

The UAE’s Ministry of Health and Prevention (MOHAP), has officially registered Beijing Institute of Biological Product’s inactivated COVID-19 vaccine as part of its efforts to combat the global pandemic.

The vaccine was registered upon request of Sinopharm CNBG.

https://www.arabnews.com/node/1774606/middle-east

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2020-12-09 13:11 | Report Abuse

@scenery I wouldnt be surprised if he is...

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2020-12-09 12:19 | Report Abuse

Did anyone know that there is such a thing as bamboo leaf tea ? Learned something new today...

https://www.topbambooproducts.com/uses-of-bamboo-leaves/

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2020-12-09 12:18 | Report Abuse

@Noobie123 Thanks...

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2020-12-09 12:10 | Report Abuse

Indonesia expects halal certificate for experimental COVID-19 vaccine

Indonesia's highest Muslim clerical body is expected to issue a halal certification for the experimental COVID-19 vaccine developed by China-based Sinovac Biotech, officials said on Monday (Dec 7)

https://www.channelnewsasia.com/news/asia/indonesia-sinovac-covid-19-vaccine-halal-certification-13719626

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2020-12-09 11:47 | Report Abuse

@see2sea Yes, certainly not for short term or contra traders. Those who always complain in this forum are most probably short term or contra traders. They do not have holding power....

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2020-12-09 11:42 | Report Abuse

One thing you need to remember when trading or investing in ANY stocks is that the amount of money that you use should be the amount of money that you are willing to lose or let go. In the stock market, nothing is 100% certain and there are bound to be risks. So the money i am using for Kanger is my spare cash which i am willing to lose. Hence, up or down, no worries for me. I will just leave it there for one year.

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2020-12-09 11:12 | Report Abuse

Its okay call me crazy or whatever, i will be holding for 1 year. I am using my spare cash so no worries for me.

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2020-12-09 10:39 | Report Abuse

@Friendship Titijaya will go down to 0.01 then lol

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2020-12-09 10:33 | Report Abuse

No idea, but i am willing to hold for 1 year to see what happens.

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2020-12-09 10:05 | Report Abuse

@Maridien2 I do not give buy or sell call unlike Friendship. You have to do your own research and make your own decision whether to join Kanger or not. I will be holding Kanger for 1 year...

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2020-12-09 09:58 | Report Abuse

@BigBladd So far NONE....

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2020-12-09 09:58 | Report Abuse

@slpless GI Healthcare will be partnering with Sinopharm to sponsor 10,000 doses of Sinopharm vaccine for use of frontliners

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2020-12-09 09:49 | Report Abuse

Titijaya totally doesnt have any MOSTI letter...LOL

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2020-12-09 09:48 | Report Abuse

@Friendship Dont be silly. Kanger is not the one distributing. It will be Zuellig Pharma distributing on behalf of Kanger...

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2020-12-09 08:07 | Report Abuse

Kanger is the only vaccine counter with khairy’s support

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Kanger says it has MOSTI's support to purchase Covid-19 vaccines for private-sector use

https://www.theedgemarkets.com/article/no-objection-kanger-purchase-covid19-vaccine

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2020-12-09 08:05 | Report Abuse

Yes holding very well compared to other vaccine counters such as bintai and solution which bled very badly.

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2020-12-09 00:13 | Report Abuse

@tradesafely Welcome...

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2020-12-09 00:12 | Report Abuse

@tradesafely Firstly, it is important to note that currently, local clinical studies are not required for registration of drug products or vaccines in Malaysia and NPRA will accept foreign clinical trial data during the registration process.

I do know something about the timeline even though i do not work at CINP unit. NPRA recently published a circular sometime this year announcing the fast-track review of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) applications with a shorter review timeline whereby the date of implementation of the circular was effective from 1 April 2020 onwards.

The criteria for fast-track review include the application of new research products used for treatment/prevention in pandemic/epidemic situations for public health except for the First-in-Human (FIH) study. You can refer the link below for further information.

https://www.npra.gov.my/index.php/en/component/content/article/40-english/circulars/1527115-pekeliling-berkenaan-pelaksanaan-prosedur-kerja-fast-track.html?Itemid=1391

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2020-12-08 23:35 | Report Abuse

@BALANCE_VIEW I can bet you that your pharma industry friend is mostly dealing with generic drug category. You can confirm that with your friend.

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2020-12-08 23:33 | Report Abuse

@BALANCE_VIEW Depends which category of drug. For new chemical entity and Biologics cateogry(including vaccines),despite a longer timeline allocated in the registration guidelines compared to say generic drug category (only 210 working days), in reality the evaluation timeline taken is usually faster for new chemical entity and biologic products (including vaccines) due to lesser backlog of submissions as well as higher percentage of products from new chemical entity and biologics product category are eligible and submitted via the priority review and facilitated registration pathway which has a shorter timeline as i have highlighted above. In reality due to insufficient number staff, the allocated timeline as stated in the registration guidelines may not achieved occasionally due to large backlog of submissions. I hope this answers your confusion on this matter.

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2020-12-08 23:10 | Report Abuse

Told you all right from the start not to trust Friendship and his fantasies......He is going to bash me again right after this...

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2020-12-08 23:00 | Report Abuse

@BALANCE_VIEW

1) Depends which registration pathway. I will not go into the details of the differences and the various conditions for eligibility of the various pathways as it is complicated and long winded to explain here. There are several types of registration pathways as follows :

(a) Normal registration pathway will take not more than 245 working days for biologics product category (including vaccines)

(b) Priority review registration pathway will take not more than 120 working days for biologics product category (including vaccines)

(c) Facilitated registration pathway :
(i) Not more than 120 working days for abbreviated review for biologics product category (including vaccines)

(ii) Not more than 90 working days for verification review for biologics product category (including vaccines)

(d) Fast track conditonal registration pathway (This is a new pathway that was very recently introduced specifically to cater for pandemic situation) :
Not more than 60 working days for biologics product category (including vaccines)

NOTE :

For (a), (b) and (c), either full registration may be given (5 years validity will be granted before renewal of registration provided complete clinical data) or conditional registration may be given (2 years validity only if clinical data provided is until phase 2 or until interim phase 3. Full clinical data must be provided prior to renewal of registration in order to be eligible for full 5 years validity)

For (d), only conditional registration with 1 year validity will be granted. The complete clinical data should be provided before renewal of registration upon which full 5 year validity should be granted.

2) I will not answer this question again which you have already asked me earlier today and i have given you the answer. If you do not believe what i explained to you earlier, then i cannot help you.

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2020-12-08 22:32 | Report Abuse

I do not have the latest data as i do not know where to find but as of 29/05/2020, 2 Perlis royalties were listed as top 30 shareholders of Kanger.

http://www.insage.com.my/ir/cmn/trps03/tsh.aspx?Symbol=0170

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2020-12-08 22:11 | Report Abuse

@eyeHunter Ok, thanks for your concern...

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2020-12-08 21:50 | Report Abuse

I will be holding....

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2020-12-08 21:45 | Report Abuse

@yingzhe17 Thanks for your concern....

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2020-12-08 18:33 | Report Abuse

Lol I just sent an email to Kanger. I wonder whether they will respond to my queries..I hope they will...

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2020-12-08 18:07 | Report Abuse

It hasn’t even started yet....

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2020-12-08 18:01 | Report Abuse

@david3app okay thanks for the valuable input..

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2020-12-08 18:00 | Report Abuse

@UlarSawa rhb investment research states Q1 2021... Hope kanger provides further updates on the status of the gloves..:

https://www.theedgemarkets.com/article/covid19-rhb-says-vaccine-deployment-could-generate-demand-18-billion-pieces-gloves-year

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2020-12-08 17:51 | Report Abuse

Mr Wu is not the managing director...

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2020-12-08 17:20 | Report Abuse

@UlarSawa Problem is there was no further update ever since that news came out in August. I wonder what’s the current status. Anyone contacted Kanger to find out ?

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2020-12-08 17:12 | Report Abuse

@UlarSawa I did promote this news quite some time ago before you joined this forum...

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2020-12-08 17:10 | Report Abuse

@BALANCE_VIEW Occasionally, NPRA may also approve drugs/ vaccines from non reference countries on a case to case basis if it meets all the requirements.

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2020-12-08 17:07 | Report Abuse

@BALANCE_VIEW NPRA also accepts WHO prequalification (ie. approval) of vaccines. WHO prequalification is internationally recognized and is on par with approval from stringent regulatory authorities from NPRA reference countries such as USA FDA and EMA. Other reference countries include Canada, Japan, Australia, Switzerland, Sweden, France and UK.

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2020-12-08 16:39 | Report Abuse

@BALANCE_VIEW No, as i mentioned above, Sinopharm vaccine phase III trial was conducted in UAE which is home to over 200 nationalities, allowing for robust research across multiple ethnicities and increasing its feasibility for global application. Hence, there is no need to provide any additional data to support the applicability of the vaccine in the Malaysian population.

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2020-12-08 16:32 | Report Abuse

@BALANCE_VIEW In addition, Sinopharm vaccine phase III trial was conducted in UAE which is home to over 200 nationalities, allowing for robust research across multiple ethnicities and increasing its feasibility for global application. Hence, there is no need to provide any additional data to support the applicability in the Malaysian population.

In certain countries like China, if the data suggests ethnic inconsistencies in effectiveness and safety, and racial sensitivity analyses do not demonstrate safety and efficacy for Chinese patients, it will only be considered “partially acceptable,” in which case a bridging study with Chinese subjects must be conducted. Hence, this is why Pfizer was required to conduct a bridging study in China despite already conducting phase III clinical trials in USA.