Pipeline

Assets	Candidate	Proposed Indication(s)	Parnterships
HPV Vaccines	Trivalent HPV Vaccine	Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers, CIN, AIN, VIN2+, VaIN2+, et al. caused by vaccine HPV types
	Nonavalent HPV Vaccine（Female indications）	Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers, CIN, AIN, VIN2+, VaIN2+, Genital warts, et al. caused by vaccine HPV types	R-Pharm*
	Nonavalent HPV Vaccine （Male indications）	Anal, oropharyngeal and other head and neck cancers, Genital warts, AIN, Genital warts, et al. caused by vaccine HPV types
	15-Valent HPV Vaccine	Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers, CIN, AIN, VIN2+, VaIN2+, Genital warts, et al. caused by vaccine HPV types	Liaoning Chengda Biotechnology**
Other Innovative Candidate Vaccines	Recombinant Bivalent COVID-19 Vaccine	COVID-19
	Recombinant Polyvalent Norovirus Vaccine	Moderate and Acute Gastroenteritis caused by vaccine Norovirus types
	Recombinant Polyvalent HFMD Vaccine	Hand, Foot and Mouth Disease (HFMD) caused by vaccine Enterovirus types
	Recombinant RSV Vaccine	LRTI and hospitalization caused by Respiratory Syncytial Virus (RSV)
	Recombinant Zoster Vaccine	Herpes Zoster
	Recombinant Poliomyelitis Vaccine	Poliomyelitis
In May 2021, Health Guard reached agreements with R-Pharm on the development and commercialization of Health Guard’s nonavalent HPV vaccine in Russia. *In January 2019, Health Guard and Liaoning Chengda Biotechnology Co., Ltd. entered into a collaboration agreement on the development and commercialization of the 15-valent HPV vaccine candidate developed by Health-Guard.

HPV Vaccines

HPV infection can cause lesions and diseases of human reproductive tract. There are over 200 types of HPV, among which 13 (HPV 16/18/31/ 33/35/39/45/51/52/56/58/59/68) are oncogenic and the primary cause of cervical cancer. Epidemiology studies indicate that almost all cervical cancer cases can be attributed to persistent infections with high-risk HPV types. Cervical cancer and pre-cancerous lesions are preventable by quality and safe HPV vaccines.

Among all HPV vaccine developers across the globe, Health Guard sports an outstanding pipeline of HPV vaccines that covers all market niches and can satisfy diverse customer needs.

Trivalent HPV Vaccine

The first HPV vaccine Health Guard develops is directed against HPV16/18/58. The trivalent HPV vaccine will theoretically afford full protection against over 78% of cervical cancer in East Asia as opposed to about 70% for the bivalent or quadrivalent HPV vaccines on the market. Clinical studies have demonstrated the Trivalent HPV vaccine is safe, well-tolerated and immunogenic. The trivalent candidate is in phase III trial, and subjects have completed the 3-dose vaccination schedule, with monitoring of endpoint cases underway.

Nonavalent HPV Vaccine

The nonavalent HPV vaccine developed by Health Guard targets 7 high-risk HPV types responsible for about 90% of cervical cancer, as well as 2 low-risk HPV types accounting for about 90% genital warts. In clinical studies, the nonavalent HPV vaccine demonstrated a good safety and tolerability profile, and elicited immune responses comparable to those of commercially available analogous products. Phase III trials of the nonavalent HPV vaccine in female indications are ongoing, subjects have completed a 3-dose series of the vaccine, and monitoring of endpoint cases is about to commence. Moreover, Health Guard is also testing the nonavalent HPV vaccine in a phase I study in healthy boys and men.

15-Valent HPV Vaccine

Health Guard is also developing a 15-valent HPV vaccine, for which the IND application has been cleared by the NMPA. The 15-valent HPV vaccine offers protection against all the 13 IRAC designated high-risk HPV types. While the nonavalent HPV vaccine can fully protect against 90% of cervical cancer, theoretically, the 15-valent HPV vaccine can further improve the protection against cervical cancer to over 96%, thus reducing the disease burden associated with HPV to a greater extent. Health Guard’s 15-valent HPV vaccine is the one that has the highest valency among all HPV vaccines cleared to start clinical trial or commercially available worldwide.

Other Innovative Candidate Vaccines

Recombinant Bivalent COVID-19 Vaccine

COVID-19 has been raging worldwide for over two years, taking a devastating toll on the global community and economy. By far, over two dozen COVID-19 vaccines based on different technology platforms have been approved or authorized for use across the globe. Inequitable access to COVID-19 vaccines, coupled with continued emergence of SARS-CoV-2 variants, urges the development of new COVID-19 vaccines that target variants on top of being accessible and affordable. Health Guard has developed and completed preclinical studies of a recombinant bivalent COVID-19 vaccine targeting both wildtype SARS-COV-2 and the Beta variant. Animal studies indicate the bivalent COVID-19 vaccine is immunogenic and offers protection against SARS-COV-2 strains. Health Guard plans to submit IND applications for the bivalent COVID-19 vaccine both in China and overseas in Q2 2022.

Recombinant Polyvalent Norovirus Vaccine

Noroviruses are leading causes of acute gastroenteritis in children and adults worldwide, responsible for approximately 699 million infections and over 219,000 deaths that accounts for approximately one-fifth of all acute gastroenteritis cases across all ages and leads to more than $4 billion in direct medical cost. Rates of diseases and deaths caused by noroviruses that need medical attention are particularly high among children under 5 years of age and seniors ages 65 and above. There is no licensed norovirus vaccine. Health Guard has identified a recombinant norovirus vaccine that targets genotypes responsible for most acute gastroenteritis cases. An IND application for the recombinant norovirus vaccine is expected to be filed in mid-2023.

Recombinant Zoster Vaccine

Herpes zoster is an acute cutaneous infection caused by reactivation of the latent varicella-zoster virus (VZV) in the human body. Herpes zoster affects approximately 1% of the population in the Asia-pacific region, with incidence increasing with age. More than 5% of those ages 40 and above will develop herpes zoster, and 9%-34% of the patients progress to post herpetic neuralgia (PHN). There is currently no treatment for herpes zoster and PHN. Vaccination is the effective means to protect against herpes zoster. Two VZV vaccines are available on the market, that is, Shingrix® (recombinant) from GlaxoSmithKline and Zostavax® (live attenuated) from Merck. Clinical trials showed that efficacy of the recombinant herpes zoster vaccine was higher than that of the live attenuated counterpart. Health Guard is working on a recombinant VZV candidate vaccine.

Recombinant RSV Vaccine

Respiratory syncytial virus (RSV) infection is one of the leading causes of deaths among infants ages one month to one year worldwide, second only to malaria. Moreover, RSV infection in the elderly often leads to exacerbation of obstructive pulmonary disease that is accompanied by cardiopulmonary complications. RSV-associated disease burden on public health is estimated to be billions of dollars. Palivizumab is the only licensed immunoprophylaxis currently available for the prevention of severe RSV disease, but it is expensive. No vaccine is approved to protect against RSV yet. Health Guard is developing a recombinant RSV vaccine.

Recombinant Polyvalent HFMD Vaccine

Hand, foot and mouth disease (HFMD) is a self-limiting infectious disease common among children under 5 years of age, which sometimes may result in serious complications involving the nervous system and heart. HFMD is mainly caused by enteroviruses, especially certain coxsackieviruses and enterovirus 71 (EV71). Currently, only vaccines targeting EV71 have been approved for marketing in China, while no vaccine against coxsackievirus is available. Health Guard aims to discover a recombinant polyvalent HFMD vaccine that offers protection against EV71 and three coxsackieviruses.