GSK Announces Major Advances: Two-Dose HPV Vaccine Schedule Approved in China and Long-Acting HIV Drug Cabotegravir Licensed to Medicines Patent Pool

Text by Li Tom and Dine

Two Key Vaccines/Drugs from GSK Advance with New Developments.

01GSK's Long-Acting HIV Drug Patent Licensed to MPP

Recently, GSK's ViiV Healthcare announced that it has granted the patent license for the long-acting HIV pre-exposure prophylaxis (PrEP) therapy cabotegravir to the MPP (Medicines Patent Pool in Geneva) and has begun negotiating the relevant voluntary licensing terms with the MPP.

ViiV Healthcare stated that both parties are working hard to achieve voluntary licensing authorization as soon as possible, with the aim of large-scale use of cabotegravir therapy for HIV pre-exposure prophylaxis in low- and middle-income countries. As of December 2021, ViiV has, through a similar deal, made a generic version of another of its HIV drugs, dolutegravir, available to at least 20 million HIV-infected individuals in low- and middle-income countries.

As early as 2014, MPP and ViiV signed a dolutegravir cooperation agreement, just two months before the therapy received European approval and eight months prior to its approval by the U.S. FDA. At that time, ViiV and MPP stated that historically, generic versions of new HIV therapies took an average of 7 to 9 years to become available in developing countries after their debut in developed nations.

ViiV and MPP Press Release: Voluntary Licenses Mark a Significant Step in Expanding Access to HIV Therapies, but "Significant Complexities and Related Concerns" RemainViiV stated that long-acting injectables like cabotegravir are more challenging to manufacture compared to oral antiretroviral drugs. Additionally, the collaboration may require capital investment, as the market demand for long-acting injectable therapies is "constantly evolving and less predictable" compared to traditional antiretroviral drugs.

To ensure the success of its licensing collaboration, ViiV stated that it will work with funders, procurement agencies, community groups, and generic drug manufacturers to find viable and sustainable solutions for the rapid production of generics. Before the availability of generic cabotegravir, ViiV commits to providing long-acting injectables at a non-profit price for public programs in low-income, least-developed countries, and all sub-Saharan African nations.

In the U.S. market, the therapy is currently being sold under the brand name Apretude. It received FDA approval in December of last year and became the first therapy that prevents HIV infection without the need for daily medication. The treatment is an integrase inhibitor, which can prevent the genetic sequence of the HIV virus from integrating into the genome of human immune cells.

Two months ago, ViiV Healthcare, a GSK-controlled HIV pharmaceutical company, announced that the U.S. FDA had approved Cabenuva (cabotegravir/rilpivirine) for the treatment of HIV-1 adolescent patients aged 12 years and older, weighing 35 kg or more, with no history of treatment failure, no known or suspected resistance to cabotegravir or rilpivirine, and who have achieved virologic suppression (HIV-1 RNA <50 copies/mL). (For details, please click on "U.S. FDA Approves GSK's Long-Acting HIV Drug Cabenuva for Adolescent Patients")

At the same time, Pfizer and Merck also reached cooperation agreements with MPP last year to promote global access to COVID-19 antiviral drugs at affordable prices.

02GSK's HPV Vaccine Cervarix Two-Dose Regimen Approved in China

Recently, GSK announced that based on the review results from the National Medical Products Administration (NMPA), its HPV vaccine Cervarix (Bivalent Human Papillomavirus Adsorbed Vaccine [HPV16/18]) has been approved for a two-dose vaccination schedule for girls aged 9-14. As a result, Cervarix has become the first imported HPV vaccine in China to be approved for a two-dose vaccination schedule for girls aged 9-14.

Persistent infection with high-risk human papillomavirus (HR-HPV) in the female reproductive tract is the leading cause of cervical cancer. Among malignant tumors of the female reproductive system in China, the incidence and mortality rates of cervical cancer rank first. In 2020, there were approximately 110,000 new cases of cervical cancer and about 59,000 deaths in China, with its incidence and mortality showing an increasing and younger trend. Epidemiological studies indicate that HPV16 and HPV18 are the most common high-risk HPV types in cervical cancer. In China, approximately 84.5% of squamous cell carcinoma cases of the cervix are associated with these two high-risk HPV types.

Vaccination against HPV in women of appropriate age will significantly reduce the incidence of cervical cancer and precancerous lesions, thereby reducing the disease burden. Since HPV is mainly transmitted through sexual contact, girls aged 9-14 who have not yet engaged in sexual activity are the primary target group for HPV vaccination. To achieve the goal of fully eliminating cervical cancer by the end of this century, the World Health Organization (WHO)’s "Global Strategy to Accelerate the Elimination of Cervical Cancer" has set a phased target for 2030, which includes ensuring that 90% of girls complete the full course of HPV vaccination before the age of 15 by 2030.

The 2017 WHO HPV Vaccine Position Paper explicitly recommends that females aged 9-14 receive two doses of the HPV vaccine. The two-dose schedule recently approved for Cervarix means that girls aged 9-14 can choose to receive one dose at month 0 and another at month 6 to complete the immunization schedule.

Studies have shown that, compared with the three-dose vaccination schedule (one dose at 0, 1, and 6 months) for females aged 15-25 years (within this age range, the vaccine efficacy of Cervarix in protecting against cervical lesions of all grades has been verified), the antibody levels induced by two doses (one dose at 0 and 6 months) in girls aged 9-14 are similar to those induced by three doses in the 15-25 age group for HPV types 16 and 18. Research indicates that the immune response in females aged 9-14 who receive two doses of Cervarix following the 0- and 6-month schedule can last for at least 60 months; mathematical models predict that the HPV16/18 antibody levels above natural infection levels produced by 95% of recipients can persist for more than 21 years after vaccination.

Currently, there are five types of HPV vaccines approved for marketing in China: the bivalent vaccine from Wantai Biologics, the bivalent vaccine from Walvax Biotechnology, the bivalent vaccine from UK's GSK, as well as the quadrivalent and nonavalent vaccines from US's Merck. Overall, the HPV vaccine remains in a state of undersupply, with a relatively low vaccination rate among eligible females in China.

Reference Source:

1、GSK's ViiV to work with Medicines Patent Pool, generic manufacturers to bolster access to long-acting HIV prevention med Apretude

2. GSK Official WeChat