Kanger (0170)
Is It True That The Process of Registering The Sinopharm Vaccine (With NPRA) Has Started?
Kanger International Bhd, an investment holding company, engages in the research, development, manufacture, and trade of bamboo flooring and related products in the People's Republic of China. It operates the business across North America, Europe, and Asia. By second halve of the year 2020, Kanger started to explore a plan for a new venture in business: to distribute the Covid-19 vaccines manufactured by Sinopharm in Malaysia. Kanger has tried hard to secure this Covid-19 vaccines business as this new business expected to bring a better results for the company.
Collaboration Agreement Signed by Kanger To Distribute Covid-19 Vaccines
Kanger International Berhad (KIB) has entered a collaboration agreement with China-based Sinopharm Group Hunan Changde Medical Co Ltd (Sinopharm Group) for the distribution of Covid-19 vaccines developed by China National Biotech Group Company (CNBG) in Malaysia.
Sinopharm Group Hunan Changde Medical Co. Ltd. is a company incorporated in the People Republic of China (“PRC”) with a business address at No. 22, 3rd Floor, Zone A, Tower 2, Long Mei Street, Changde Economic and Technological Development Changde, Hunan Province, PRC. Group Hunan Changde Medical Co. Lt.d is principally engaged in sale of medical supplies and equipment, and is part of Sinopharm Group, which is a large Chinese state-owned healthcare group.
The existence the Sinopharm Group Hunan Changde Medical Co. Ltd. and its relations with Sinopharm Group of company can be verified as per the web link (http://www.info-clipper.com/en/company/china/sinopharm-holding-hunan-changde-medical-equipment-co-ltd.cnd9657ed.html). And also, there is an evidence base on the report that, "Kanger will receive 10,000 doses of a Covid-19 vaccine developed by state-owned China National Pharmaceutical Group Corp Sinopharm) for trial purposes." (https://www.theedgemarkets.com/article/kanger-receive-10000-doses-sinopharm-covid19-vaccine%C2%A0-may-trial-purposes ). Therefore, Kanger suppose to import the Sinopharm vaccine via Sinopharm Hunan Changde Medical Co. Ltd.'s dealearship.
Based on the filing on Bursa Filing by KIB on 29th September 2020 it has reported that under the agreement, Sinopharm Group has appointed KIB as the sole distributor for the vaccines, medical devices and products in Malaysia. KIB will also undertake the marketing and promotion of Sinopharm Group's products in Malaysia, however, both parties will sign a separate agreement in regards to specific product category, price, purchase price and payment method. This agreement shall take effect for a period of three years effective from 25 September 2020 until 24 September 2023.
There are two Covid-19 vaccines developed by Sinopharm which are Sinopharm / BIBP1 or SARS-CoV-2 - BIBP1 and Sinopharm / WIBP1 or SARS-CoV-2 - WIBP1. Sinopharm / BIBP1 vaccine was developed through a collaboration between the Chinese Center for Disease Control and Prevention (CDC) and the Beijing Institute of Biological Products (BIBP)/China National Biotec Group Company Limited (CNBG). Sinopharm and CNBG's entity, the Wuhan Institute of Biological Products developed another vaccine, Sinopharm / WIBP1 or SARS-CoV-2 - WIBP1.
CNBG involved in colloborations for developing both of the Covid-19 vaccines produced by Sinopharm, therefore there is a probability for Kanger to be involved in both of Sinopharm vaccine distribution in Malaysia.
How to secure the Covid-19 vaccine businesses in Malaysia?
One of the major aspect to be done is to make sure that the Sinopharm vaccines is approve in Malaysia, including by the National Pharmaceutical Regulatory Agency (NPRA). The NPRA’s reference and standards in evaluating Covid-19 vaccine dossiers are based on guidelines issued by the National Regulatory Authority of other countries, including the World Health Organization, European Medicines Agency and others. The NPRA works closely with companies and manufacturers to ensure they can immediately furnish the complete information for each application.
Today, I just received an information about the Covid-19 vaccine registration status by WHO stated in a list entitled Status of COVID-19 Vaccines within WHO EUL/PQ Evaluation Process. The Guidance Document dated 28th May 2021 shows the data of all the Covid-19 candidates that has been approved and under assessment status for approval, including the data about two Sinopharm Covid-19 vaccines registration progress. The list is as below:
Based on the data given in the list, there are two Sinopharm Covid-19 vaccines’s application for WHO's approval has been submitted. One of the Sinopharm Covid-19 vaccine, Sinopharm / BIBP1 or SARS-CoV-2 - BIBP1 was approved for emergency use on 7th May 2021 and the other one, Sinopharm / WIBP1 or SARS-CoV-2 - WIBP1 is still at primary stage of approval.
Therefore, as Sinopharm vaccine was approved by WHO, there is a chance of the vaccine to be assess by Malaysian NPRA with a good potential to be approved.
The Process of Registering The Sinopharm Vaccine (With NPRA)
Related to this Sinopharm vaccines approval issue, there are reports concerning the progress of Sinopharm vaccine registration can be sought in the web. Reported that:
Report 1: The Sinopharm Covid-19 vaccine is in the process of being approved in Malaysia, including by the National Pharmaceutical Regulatory Agency (NPRA).
(Source: https://www.theedgemarkets.com/article/kanger-signs-mou-sabah-govt-procure-chinas-sinopharm-covid19-vaccines ).
Report 2: Kanger International executive director Steven Kuah told reporters that, “the process of registering the Sinopharm vaccine (with NPRA) has started and we hope to receive some good news on its approval soon.”
The Sinopharm / BIBP1 vaccine has been approved by WHO, whereas the Sinopharm / WIBP1 is still under its assessment process by WHO. Therefore, it’s better for Kanger to focus more on the currently approved vaccine by WHO, which is Sinopharm / BIBP1 for NPRA's approval. We, the investors of Kanger hope to receive some good news on its approval soon.
** DISCLAIMER: I wrote this article based on my research from www.bursamalaysia.com and information reported on the web. All information given should not be considered as an investment advice. Please do your own analysis or consult your qualified financial advisor for advice. All information is not a buy call or a sell call in any securities transactions.
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UPDATED NEWS...
KJ sahkan ada pihak tempatan cuba daftar vaksin Sinopharm
Menteri Penyelaras Program Imunisasi COVID-19 Kebangsaan sahkan terdapat beberapa pihak tempatan yang sedang cuba mendaftarkan vaksin Sinopharm dihasilkan syarikat farmaseutikal dari China. Vaksin sinopharm tidak termasuk di dalam Program Imunisasi COVID-19 Kebangsaan (PICK). Kata Khairy Jamaluddin, perkara berkenaan adalah dibenarkan dan pihaknya mengalu-alukan perkara tersebut. (May 21, 2021)
Sumber: https://www.astroawani.com/video-malaysia/covid-19-kj-sahkan-ada-pihak-tempatan-cuba-daftar-vaksin-sinopharm-1905361
2021-06-06 04:38
Kelulusan WHO tingkatkan keyakinan terhadap vaksin Sinovac - Khairy (2 Jun 2021)
Kelulusan Pertubuhan Kesihatan Sedunia (WHO) terhadap vaksin COVID-19 Sinovac akan meningkatkan keyakinan terhadap pengambilan vaksin tersebut.
Menurut Menteri Penyelaras Program Imunisasi Covid-19 Kebangsaan (PICK) Khairy Jamaluddin Abu Bakar, ini membuktikan vaksin tersebut selamat dan berkesan.
Sumber: https://www.astroawani.com/berita-malaysia/kelulusan-who-tingkatkan-keyakinan-terhadap-vaksin-sinovac-khairy-301080
2021-06-06 20:28
WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations
7 May 2021 News release Reading time: 3 min (917 words)
WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).
2021-06-08 14:40
Diketepi dari MKN, menteri tegur cara k'jaan kendali vaksin, PPV
"Contoh kalau dunia boleh menerima penggunaan vaksin menerusi EUL (Senarai Kegunaan Darurat) dari negara asalnya dan WHO, kita harus menggunakannya untuk mendapatkan bekalan vaksin yang lebih beragam.
"Kita tak boleh hanya bergantung pada Covax dan NPRA untuk meluluskannya. Contoh hari ini ada vaksin lain seperti Sputnik V dan Sinopharm," tambahnya.
https://www.malaysiakini.com/news/578265
2021-06-09 19:29
An update on the prospect of Kanger to be involved as the distributor of Sinopharm Covid-19 vaccine in Malaysia:
Report 1: 9 March 2021.
Kanger International Bhd will receive 10,000 doses of a Covid-19 vaccine developed by state-owned China National Pharmaceutical Group Corp (Sinopharm) for trial purposes.
In a bourse filing today, the group said the 10,000 doses of the vaccine will be for trial purposes and that it will be getting the necessary approvals from the relevant authorities.
“The first batch of vaccines is expected to arrive in May 2021,” Kanger stated.
Sinopharm has Covid-19 vaccine candidates that are undergoing stage 3 clinical trials
Source: https://www.theedgemarkets.com/article/kanger-receive-10000-doses-sinopharm-covid19-vaccine%C2%A0-may-trial-purposes
Report 2: 21 May2021.
The government is open to any party that has the capability and clinical data of the Sinopharm Covid-19 vaccine to register it with the National Pharmaceutical Regulatory Agency (NPRA), says Khairy Jamaluddin (pic).
The National Covid-19 Immunisation Programme coordinating minister said that this DID NOT HAVE TO GO THROUGH PHARMANIAGA, the local registration product holder for the Sinovac vaccine.
He said there were several parties interested in bringing the Sinopharm vaccine from China.
“It can go through anybody else who wants to try and bring in the vaccine. It can be registered with the NPRA,” he said in a video late Thursday (May 20) to address several allegations made by Opposition leader Datuk Seri Anwar Ibrahim about the immunisation programme.
Source: https://mywinet.com/covid-19-those-who-want-to-bring-in-sinopharm-vaccine-can-register-it-with-npra-says-khairy/
Report 3: 27 May2021.
“the process of registering the Sinopharm vaccine (with NPRA) has started and we hope to receive some good news on its approval soon.”
Source: https://www.freemalaysiatoday.com/category/nation/2021/05/27/sabah-signs-mou-with-private-firm-to-obtain-sinopharm-vaccine/
MY FINDINGS:
1. Kanger planned to bring Sinopharm Covid-19 vaccine for trial purposes.
2. Until 21 May 2021, the Sinopharm Covid-19 vaccine was not registered with NPRA yet.
3. There will be a big probability that the report by Kanger official is true. The company has started to register the said vaccine with NPRA.
2021-06-22 09:49
On the Sputnik Covid-19 vaccine produced by Russia, Khairy said that Duopharma Biotech Bhd’s wholly-owned subsidiary, Duopharma (M) Sdn Bhd (DMSB), which holds the distribution rights to the product, has three months to register the vaccine with the National Pharmaceutical Regulatory Agency (NPRA), after inking an agreement with the government earlier this month.
He said that the NPRA still requires further information on the vaccine.
“However, NPRA also said that it would simplify the registration process if Sputnik gets emergency use (status) from the World Health Organisation (WHO). Sputnik has not received the EUL from WHO yet,” he said, referring to the Emergency Use Listing.
Source: https://www.malaymail.com/news/malaysia/2021/06/21/khairy-cansino-vaccine-to-arrive-in-malaysia-next-month-no-updates-yet-on-j/1983852
2021-06-22 09:50
“However, NPRA also said that it would simplify the registration process if Sputnik gets emergency use (status) from the World Health Organisation (WHO).
--------------------
I want to stress on this.
If the Sinopharm was truly just registered with NPRA, the process of approval should be more shorter in time compared with the vaccine candidate which not been approved by WHO yet.
Note: Sinopharm vaccine has been approved by WHO.
2021-06-22 09:50
1. Until 21 May 2021, the Sinopharm Covid-19 vaccine was not registered with NPRA yet.
As per report on 21 May 2021: "The government is open to any party that has the capability and clinical data of the Sinopharm Covid-19 vaccine to register it with the National Pharmaceutical Regulatory Agency (NPRA)", says Khairy Jamaluddin.
2. The earliest registering date with NPRA can posibly be done after 21 May 2021.
3. Reports by Kanger official on 27 May 2021 stated that Kanger has started the process of registering the Sinopharm vaccine with NPRA.
As per report: “the process of registering the Sinopharm vaccine (with NPRA) has started and we hope to receive some good news on its approval soon.”
Source: https://www.freemalaysiatoday.com/category/nation/2021/05/27/sabah-signs-mou-with-private-firm-to-obtain-sinopharm-vaccine/
2021-06-23 12:45
Dr Noor Hisham: NPRA set to announce Sinopharm’s inclusion in Covid-19 immunisation plan
“Tomorrow the NPRA will meet and we will consider the Sinopharm vaccine, which was approved by the World Health Organisation.
“Their company just sent their dossiers to us, and in less than a month we have evaluated and will give our decision on the conditional approval tomorrow,” he said.
Source: https://malaysia.news.yahoo.com/dr-noor-hisham-npra-set-111805262.html
2021-07-15 20:58
The Board of Directors of Kanger (“Company”) wishes to announce that Kanger Medical International Sdn. Bhd., a wholly-owned subsidiary of the Company had, on 19 July 2021 entered into Head of Agreement with Sparmak Medical Equipment Trading LLC for purchase of inactivated SARS-COV-2 Vaccines (Vero Cell) vaccine developed by Beijing Institute of Biological Products Co. Ltd., an affiliate of SINOPHARM CNBG.
Please refer to the full announcement as attached.
This announcement is dated 19 July 2021.
Source: https://www.bursamalaysia.com/market_information/announcements/company_announcement/announcement_details?ann_id=3176295
4.1 Quantity and specification of the Products
Quantity: Five Million (5,000,000) doses with an option to buy an additional Five Million (5,000,000) doses.
Specification: SARS COV-2 vaccine (Vero cell) inactivated, 6.5 U/0.5ml in prefilled syringe or vial (as per availability) and pack size either 2 doses per vial per box or Single dose per vial per box (as per availability). The Product is manufactured by Gulf Pharmaceutical Industries Julphar in the United Arab Emirates (HAYAT-VAX), i.e. G42 Medications Trading LLC (“Manufacturer”).
2021-07-19 17:41
Earlier this year, Sinopharm entered into a joint venture with UAE-based G42 to produce the Sinopharm Covid-19 vaccines in the country under the Hayat-Vax brand.
The made-in-UAE vaccine was the first Covid-19 vaccine to be produced in the Arab world.
"The Hayat-Vax vaccine is essentially the same Sinopharm Covid-19 vaccine, manufactured in the UAE. Hence, we are confident that it will be well-received and accepted by the Malaysian people as an effective vaccine towards the global fight against the Covid-19 pandemic," said Kuah.
Kanger has also been authorised by G42 to be the product registration holder and distributor of the Hayat-Vax vaccine in Malaysia.
On behalf of G42 Medications, Kanger said it had submitted applications to obtain the required approvals from the National Pharmaceutical Regulatory Agency for the Hayat-Vax vaccine to be used in Malaysia.
2021-07-19 17:42
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Tambahnya, setakat ini, terdapat enam produk vaksin Covid-19 yang telah selesai dinilai oleh NPRA dalam masa yang ditetapkan dan telah mendapat kelulusan pendaftaran bersyarat daripada PBKD.
Katanya, pihak NPRA juga sedang menilai BEBERAPA PERMOHONAN BAHARU bersyarat vaksin-vaksin Covid-19 pada masa ini.
“Permohonan ini juga akan disegerakan dengan kaedah yang sama. NPRA sememangnya sentiasa terbuka menerima pandangan pelbagai pihak,” katanya
Source: https://www.kosmo.com.my/2021/05/25/npra-nafi-lewat-lulus-produk-vaksin-covid-19/
2021-06-05 17:30