Pakistan Pharma Among World's Top 3 Fastest Growing

Pakistan pharmaceutical industry and market are among the world's top 3 fastest growing, according to IQVIA health market research firm based in the United States. Pakistan’s domestic pharmaceutical firms sales have grown 13.1% compounded annually in the last 4 years, outperforming multinational companies (MNCs), which saw global growth of 9.34% CAGR. Pakistan's pharma sector is growing faster than in other emerging markets like Bangladesh, Brazil, India, Russia and Vietnam.

Emerging faster than the MNCs, the quarterly revenues of the local Pakistani pharmaceutical companies surged to Rs. 320 billion in the quarter ending March 31, 2020, compared with Rs. 195.75 billion as of March 31, 2016. Similarly, MNCs increased their quarterly sales in Pakistan to Rs. 143.2 billion at the end of the first quarter of 2020, up from Rs. 100.2 billion in Q12016, according to Pakistani media reports. Pakistan exported $217.04 million worth of pharma products during 2019, according to the United Nations COMTRADE database on international trade.

Pakistan Pharma Growth Among Top Fastest in the World. Source: IQVIA

Medicine spending growth in the emerging pharmaceutical  ("pharmerging") markets continues to slow compared to the past five years and is projected to grow at 5–8% through 2023, according to US-based global market research firm IQVIA.

Pakistan Pharma Exports

Although China, Brazil and India have the largest medicine spending within the pharmerging markets, Turkey, Egypt and Pakistan are forecast to have the greatest growth between 2019 and 2023. Pharmerging market growth continues to derive primarily from increasing per capita use, but some markets are seeing wider uptake of newer medicines as patients’ ability to afford their share of costs improves with economic growth.

Pakistan's top 5 pharma companies, including GSK, Abbott, and AGP Pharma,  saw their profits jump 37% in Q1/2020 over the same period last year, to Rs2.6 billion. In the same quarter, profits of 13 consumer giants, including Nestle, Packages, Pakistan Tobacco and Colgate, remained flat amid COVID19 pandemic.

In growing recognition of Pakistan's pharmaceutical sector, the  US-based Gilead Sciences recently chose to license COVID19 drug Remdesivir to Pakistan's Ferozsons pharmaceutical company. Other Remdisivir licensees include pharma companies in India. Gilead said it signed non-exclusive licensing pacts with 5 generic drugmakers based in India and Pakistan, allowing them make and sell Remdesivir for 127 countries.

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Comment by Riaz Haq on April 2, 2021 at 5:14pm

China approves clinical trials for Livzon Pharma unit's COVID-19 vaccine

https://www.reuters.com/article/us-health-coronavirus-vaccine-livzo...

China’s medical products regulator has approved clinical trials for a COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc, the Chinese company said late on Tuesday.

The potential vaccine joins more than ten candidates that Chinese scientists have moved into human testing, with four of them now cleared for wider public use and one for limited emergency use.

The protein-based injection, dubbed V-01, could be transported and stored at normal refrigerator temperatures of 2-8 degrees Celsius, Livzon Pharma said in a filing, without giving further details.

As of the end of February, Livzon had invested 67 million yuan ($10.3 million) into researching and developing the candidate, which is being jointly developed by its subsidiary based in the southern Chinese city of Zhuhai and the Institute of Biophysics of Chinese Academy of Sciences.

Separately, CanSino Biologics Inc, whose injection-based vaccine has been used in China and secured supply deals with countries including Pakistan and Mexico, said earlier on Tuesday it had obtained approval from China’s National Medical Products Administration to conduct human testing for a COVID-19 vaccine candidate administered via inhalation.

Comment by Riaz Haq on April 2, 2021 at 7:03pm

What are protein subunit vaccines and how could they be used against COVID-19? | Gavi, the Vaccine Alliance (Example: Livzon-Searle Pakistan covid19 vaccine)

http://www.gavi.org/vaccineswork/what-are-protein-subunit-vaccines-...

HOW DO SUBUNIT VACCINES TRIGGER IMMUNITY?

Subunit vaccines contain fragments of protein and/or polysaccharide from the pathogen, which have been carefully studied to identify which combinations of these molecules are likely to produce a strong and effective immune response. By restricting the immune system’s access to the pathogen in this way, the risk of side effects is minimised. Such vaccines are also relatively cheap and easy to produce, and more stable than those containing whole viruses or bacteria.

A downside of this precision is that the antigens used to elicit an immune response may lack molecular structures called pathogen-associated molecular patterns which are common to a class of pathogen. These structures can be read by immune cells and recognised as danger signals, so their absence may result in a weaker immune response. Also, because the antigens do not infect cells, subunit vaccines mainly only trigger antibody-mediated immune responses. Again, this means the immune response may be weaker than with other types of vaccines. To overcome this problem, subunit vaccines are sometimes delivered alongside adjuvants (agents that stimulate the immune system) and booster doses may be required.

HOW EASY ARE THEY TO MANUFACTURE?

All subunit vaccines are made using living organisms, such as bacteria and yeast, which require substrates on which to grow them, and strict hygiene to avoid contamination with other organisms. This makes them more expensive to produce than chemically-synthesised vaccines, such as RNA vaccines. The precise manufacturing method depends on the type of subunit vaccine being produced. Protein subunit vaccines, such as the recombinant hepatitis B vaccine, are made by inserting the genetic code for the antigen into yeast cells, which are relatively easy to grow and capable of synthesising large amounts of protein. The yeast is grown in large fermentation tanks, and then split open, allowing the antigen to be harvested. This purified protein is then added to other vaccine components, such as preservatives to keep it stable, and adjuvants to boost the immune response – in this case alum. For polysaccharide or conjugate vaccines, the polysaccharide is produced by growing bacteria in industrial bioreactors, before splitting them open and harvesting the polysaccharide from their cell walls. In the case of conjugate vaccines, the protein that the polysaccharide is attached to must also be prepared by growing a different type of bacteria in separate bioreactors. Once its proteins are harvested, they are chemically attached to the polysaccharide, and then the remaining vaccine components added.



Comment by Riaz Haq on April 2, 2021 at 7:05pm

V-01 is an innovative novel coronavirus recombinant protein vaccine developed by Livzon and the Institute of Biophysics, Chinese Academy of Sciences. V-01 belongs to the technical route of recombinant protein vaccine among the other five technical routes of the novel coronavirus vaccine, which can be transported and stored at 2-8°C.

During the development of V-01, Shanghai Medicilon Inc. (Medicilon) undertook the drug safety evaluation. Since the establishment of the V-01 project, Medicilon has relied on a strong technical team and R&D platform to gather experts, technology, equipment and other resources in order to shorten the R&D time.

The development of a novel coronavirus vaccine is a battle against time and the virus. The colleagues of Medicilon who participated in the development of V-01 worked overtime and overcome the difficulties during the development continuously in 4 months to ensure that every experiment is carried out on time and every analysis results are provided on time.

Medicilon congratulates Livzon on its milestone and wishes V-01 will be launched soon to help prevent and control the novel coronavirus epidemic. Medicilon is proud to be a part to contribute the research and development of the novel coronavirus vaccine.

About Livzon
Livzon Pharmaceutical Group Inc., established in January 1985 with registered capital of RMB 953 million, is a comprehensive pharmaceutical group company integrating pharmaceutical R&D, production and sales, with more than 9,000 employees. In 1993, Livzon A and B shares have been listed. In 2014, the company completed the conversion from B shares to H shares, making it one of the few listed pharmaceutical companies with A+H shares in the capital market.

Livzon is committed to ensuring effective, safe and stable products. The Group’s pharmaceutical enterprises have established a sound quality management system. As of 2018, Total 31 production lines of 4 pharmaceutical subsidiaries have passed GMP certification. 28 varieties of 4 API companies have passed GMP certification and other 11 varieties have passed veterinary medicine GMP certification. 15 API varieties have passed the field inspection of international certification and obtained 20 international certification certificates.



https://www.medicilon.com/medicilon-assists-livzon-pharmaceuticals-...

Comment by Riaz Haq on April 3, 2021 at 12:53pm

Pakistan’s Searle Company has entered into an agreement with a Chinese firm to manufacture the coronavirus vaccine in Pakistan. This is the first contract Pakistan has signed with a pharmaceutical company to begin the domestic production of COVID-19 vaccine.

https://gulfnews.com/world/asia/pakistan/pakistan-firm-signs-covid-...

“The Searle Company has concluded an exclusive licensing and supply agreement with Livzon Mapharm Inc. for the recombinant novel coronavirus vaccine (V-01)” reads the firm’s April 1 letter to the Pakistan Stock Exchange (PSX). The contract also covers the manufacturing transition of the V-01 vaccine in Pakistan.

The vaccine developed by China’s Livzon Pharmaceutical Group had shown promising results in phase I and II clinical trials. The phase III trial would enroll 20,000 people in multiple countries to evaluate the efficacy, safety, and immunogenicity of the vaccine, the company said.

Among the many COVID-19 vaccine projects around the world, “V-01 has many potential advantages such as strong safety profile, high neutralising antibody titres, long durability and easy to scale up manufacturing” the document said. The protein-based vaccine V-01 could be transported and stored at normal refrigerator temperatures at 2-8 degrees Celsius.

Urgent basis
Pakistani private pharmaceutical company hoped that government officials and relevant authorities would “take up the matter on urgent basis and support for fast-track approval to carry out phase III clinical trials in Pakistan” to pave the way for local vaccine manufacturing. Searle has two state-of-the-art manufacturing facilities in Lahore and Karachi.

Experts have urged the government to initiate local production of the vaccines to speed up the vaccination process in the country of 220 million people. Health professionals believe the pandemic has opened the way for health transformation in Pakistan and offers the country the opportunity to advance its medical research and develop domestic biomanufacturing capacity to make the country self-sufficient and better prepared for the future.

Pakistan earlier announced that it would import China’s CanSino COVID-19 vaccine in bulk to package three million doses locally at the National Institute of Health (NIH) in Islamabad.

Pakistn has so far approved four vaccines for use in the country – China’s Sinopharm and Cansino, Russia’s Sputnik V and Oxford University’s AstraZeneca

Comment by Riaz Haq on April 5, 2021 at 6:45pm

For the United States there are three different influenza vaccine production technologies approved by the U.S. Food and Drug Administration (FDA)external icon:

egg-based flu vaccine,
cell-based flu vaccine, and
recombinant flu vaccine.
All commercially available flu vaccines in the United States are made by private sector manufacturers. Different manufacturers use different production technologies, but all flu vaccines meet FDA safety and effectiveness requirements. Different vaccines have different indications. See Influenza Vaccines — United States, 2019-2020 Influenza Season for specific indications.


https://www.cdc.gov/flu/prevent/how-fluvaccine-made.htm



There is a third production technology for flu vaccines that was approved for use in the U.S. market in 2013 and that involves using recombinant technologyexternal icon. Recombinant flu vaccines do not require having a candidate vaccine virus (CVV) sample to produce. Instead, recombinant vaccines are created synthetically. To make a recombinant vaccine, flu scientists first obtain DNA, i.e., genetic instructions, for making a surface protein called hemagglutinin (HA) found on influenza viruses. HA is an antigen, which is a feature of a flu virus that triggers the human immune system to create antibodies that specifically target the virus. This DNA for making flu virus HA antigen is then combined with a baculovirus, a virus that infects invertebrates. This results in a “recombinant” virus. The role of the baculovirus is to help transport the DNA instructions for making flu virus HA antigen into a host cell. Once the recombinant virus enters a Food and Drug Administration (FDA) qualified host cell line, it instructs the cells to rapidly produce the HA antigen. This antigen is grown in bulk, collected, purified, and then packaged as recombinant flu vaccine. These vaccines are then quality and potency tested by FDA prior to FDA approving release of the vaccine lots to the public.

Comment by Riaz Haq on June 5, 2021 at 7:22am

Citi Pharma to raise Rs2.8 billion in IPO

https://nation.com.pk/05-Jun-2021/citi-pharma-to-raise-rs2-8-billio...

Pakistan based Citi Pharma Ltd is planning to raise up to Rs2.8 billion by offering a 35 per cent stake to institutional and ordinary investors in an initial public offer (IPO) on the Pakistan Stock Exchange (PSX).

The book building phase of the IPO will he held on 15th and 16th June where high net worth individuals and financial institution will participate. The company will issue all new shares through book building at the floor price of Rs28 per share, which includes a premium of Rs18 apiece. It means Citi Pharma is guaranteed to raise at least Rs2 billion in the IPO. However, based on the interest from investors during the book building process, the strike price can rise by 40 per cent (Rs39.20 a share), thus helping the company collect Rs2.8 billion. After the book building process, successful bidders will be provisionally allotted 75 per cent of the issue size (54.5 million shares). The remaining 25 per cent (18.1 million shares) will then be offered to retail investors at the strike price.

Although the company makes many drugs for consumers, its major source of revenue is the manufacturing and sale of active pharmaceutical ingredients (APIs) — key substances that make a finished pharmaceutical product. Major drug makers like GlaxoSmithKline, The Searle Company, Barret Hodgson and Martin Dow buy their APIs from Citi Pharma. Citi Pharma is raising new funds for three major reasons. Firstly, the company is planning to expand its existing capacity of 3,600 tonnes per annum of paracetamol to 6,000 tonnes per annum. That’s partly because the demand for paracetamol has surged in the wake of Covid-19. In addition, the company says it plans to add new APIs as well as pharmaceutical formulations (final products) to its existing product line.

The pharma industry in Pakistan is worth Rs501 billion. It grew at an annualised growth rate of 11.4 per cent between 2016 and 2020. Of the 650 pharma companies, only 31 are multinationals. Local firms have a collective share of 60 per cent while multinationals control the rest of the market.

Citi Pharma’s revenue was a little more than Rs1 billion in 2015-16, which grew to Rs3.5 billion in 2019-20. This reflects an annualised growth rate of 36.5 per cent. Similarly, net profit for 2019-20 was Rs145.6 million after increasing at an annual average of 27.7 per cent. Net profit for the first half of 2020-21 amounted to Rs168.5 million.

Comment by Riaz Haq on July 19, 2021 at 10:34am

Ministry of science and technology to facilitate vaccine development process in Pakistan: Shibli Faraz


https://dailytimes.com.pk/791345/ministry-of-science-and-technology...

In his introductory remarks, Coordinator General, COMSTECH, Prof. Dr. M. Iqbal Choudhary, welcomed the participants and said that it is our national responsibility to use our capabilities to help in the development of human vaccines.

He assured that COMSTECH would provide every sort of possible support in this regard.

The meeting was attended by representatives from private sector leading pharmaceutical companies of Pakistan including Searle Pakistan Ltd, Ferozsons Laboratories, Amson Vaccines and Pharma, and Getz Pharma (Pvt). Ltd, Focus and Rulz Pharmaceuticals (Pvt.) Limited.

In addition, senior officials and experts of premier R&D institutions of Pakistan i.e. National Institute of Health (NIH), International Center for Chemical and Biological Sciences, University of Karachi, National Center for Biotechnology and Genetic Engineering, Faisalabad, Centre Excellence for Molecular Biology, University of Punjab were present in the meeting.

This meeting was started with the introduction of participants, their existing capacities in the field of manufacturing biologics and vaccines.

Detailed discussion was carried out for the enabling role of the Government of Pakistan.

Pharmaceutical companies explained in depth the bottlenecks faced by the industries to stay abreast with changes in the manufacturing of vaccines and biologics.

The Minister for Science and Technology entrusted responsibility to COMSTECH and National Institute of Health (NIH) for preparing a position paper to facilitate the industries and create sustainable linkage between industry and Research and Development institutions of Pakistan.

Comment by Riaz Haq on June 1, 2022 at 7:21am

India wants to be the ‘pharmacy of the world.’ But first, it must wean itself from China

https://www.cnbc.com/2022/05/27/india-needs-to-fill-china-gaps-to-b...

India has embarked on an ambitious plan to cut dependence on China for key raw materials as it seeks to become self-sufficient in its quest to be the “pharmacy of the world.”
However, India’s $42 billion pharmaceutical sector is heavily dependent on China for key active pharmaceutical ingredients or API — chemicals that are responsible for the therapeutic effect of drugs.
Estimates put India’s dependence on China at as much as 90% for certain drugs.

an estimate by the Trade Promotion Council, a government supported organization, puts the figure of API dependence on China at about 85%. Another independent study carried out in 2021 points out that while India’s API imports from China are at nearly 70%, its dependence on China for “certain life-saving antibiotics” is around 90%. Some drugs that are highly dependent on Chinese APIs include penicillin, cephalosporins and azithromycin, the report said.

That may be starting to change.

Under a government scheme launched two years ago, 35 APIs began to be produced at 32 plants across India in March. This is expected to reduce dependence on China by up to 35% before the end of the decade, according to an estimate by ratings firm ICRA Limited, the Indian affiliate of Moody’s.

The production linked incentive scheme was first launched in mid-2020, when military tensions with China were at a high. The PLI program aims to incentivize companies across all sectors to boost domestic manufacturing by $520 billion by 2025.

For the pharma sector, the government has earmarked over $2 billion worth of incentives for both private Indian companies and foreign players to start producing 53 APIs that India relies heavily on China for.

Some of India’s biggest pharmaceutical companies are involved in the scheme. They include Sun Pharmaceutical Industries, Aurobindo Pharma, Dr. Reddy’s Laboratories, Lupin and Cipla.

A total of 34 products were approved in the first phase of the scheme — and distributed amongst 49 players, according to assistant vice president at ICRA Limited, Deepak Jotwani.

“The first phase will result in reduction in imports from China by about 25-35% by 2029,” Jotwani estimated.

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