Genting Sun Yew announced that its mRNA vaccine candidate has achieved positive top-line results in the adult primary immunization phase II trial, and is submitting a Phase III clinical trial application for booster vaccine vaccine overseas, with a local manufacturing facility soon to be operational

Genting Sun Yao (HKEX 1952.
HK), a biopharmaceutical company focused on the development and commercialization of innovative drugs to meet unmet medical needs in the Asia-Pacific market, announced on October 19 that its partner Providence Therapeutics Holdings Inc.
("Providence") has an mRNA vaccine candidate PTX-COVID19-B in evaluating its safety, Positive top-line results
were achieved in phase II studies of tolerability and immunogenicity.
Genting Sun Yew acquired corresponding rights and interests in PTX-COVID19-B in Greater China, Southeast Asia and Pakistan from Providence in 2021, and has also established extensive collaborations to leverage this technology platform to develop mRNA products
globally.

The geometric mean titer (GMT) ratio of neutralizing antibodies observed two weeks after the second intramuscular injection of PTX-COVID19-B was statistically non-inferior
in terms of Comirnaty®, an FDA-approved mRNA vaccine (jointly developed by Pfizer and BioNTech).
In addition, PTX-COVID19-B is well tolerated overall, with safety and tolerability similar
to Comirnaty®.

The phase II study enrolled 565 participants
aged 18 to 64 at multiple sites in Canada and South Africa.
374 subjects were vaccinated with PTX-COVID19-B and were well tolerated overall, with tolerability similar
to Comirnaty®.
The overall incidence of solicited all-cause adverse events (AEs) after the first and second doses of the vaccine was similar in both groups: PTX-COVID19-B was 71.
6% and 59.
0%, respectively, and Comirnaty® was 74.
2% and 62.
4%,
respectively.
After the first and second doses, locally solicited adverse events were 62.
6% and 53.
8% for PTX-COVID19-B and 65.
1% and 57.
1%
for Comirnaty®, respectively.
After the first and second vaccinations, systemic solicited adverse events for PTX-COVID19-B were 49.
7% and 36.
9%, respectively, and Comirnaty® was 58.
6% and 45.
3%,
respectively.
The proportion of participants in the PTX-COVID19-B group reporting non-solicited adverse events was also similar to that of the Comirnaty® group (53.
7% and 52.
4%)
.
No non-solicited serious adverse events (SAEs) related to vaccination were reported
in either group.

Immunogenicity analysis showed that the neutralizing antibody titer GMT produced after 2 weeks of receiving two doses of PTX-COVID19-B was statistically non-inferior compared with Comirnaty® (0.
84, 95% confidence interval, CI: 0.
69 to 1.
02).

Analysis two weeks after the second dose also showed that the serum response rate was also non-inferior
.
In an important subgroup analysis in people with serally confirmed absence of prior infection or vaccination, the immune response induced by PTX-COVID19-B two weeks after the second dose was not inferior to Comirnaty® (1.
23, 95% confidence interval, CI: 0.
95 to 1.
58).

Genting Sun Yao CEO Yong King Lo said, "Congratulations to our mRNA vaccine candidate for exciting data
in Phase II trials.
To our knowledge, this is the first clinical study
to directly compare candidate seedlings with approved mRNA vaccines.
We are committed to jump-starting Phase III trials and rolling out our COVID seedlings
in authorized regions as soon as possible.
Since the completion of the transaction with Providence, we have made significant progress, including the completion of clinical-scale technology transfers and the imminent commissioning of a commercial-scale local manufacturing facility in Jiashan
, Zhejiang Province.
We look forward to applying this advanced and clinically proven mRNA technology platform as a long-term growth driver
for Genting Sunnyao mRNA seedlings and new drug business.
" ”

Genting Sun Yew is submitting a Phase III clinical trial (IND) application with partners to evaluate the safety and immunogenicity
of PTX-COVID19-B as a booster shot.
The Company plans to submit a clinical trial application
for Omicron's bivalent booster vaccine candidate EVER-COVID19-M1.
2 in China and other Genting Sunshine authorized regions in the second half of 2022.

Located in Jiashan, Zhejiang Province, the mRNA seedling manufacturing plant covering an area of 85 acres, with considerable investment scale and advanced facilities will soon be put into operation, which will enable Genting Sun Yao to better realize the localized R&D, production and efficient commercial operation of the mRNA technology platform, based in China, and looking at the unmet demand
for mRNA seedlings and innovative drugs in the Asian market.

About Phase II Study PRO-CL-002

PRO-CL-002 (ClinicalTrials.
gov number NCT05175742) is an ongoing randomized, dual-simulation, observer-blinded, phase II study to evaluate the safety, tolerability, and immunogenicity
of 40 μg of PTX-COVID19-B compared to Comirnaty® in healthy, SARS-CoV-2 seronegative adults aged 18 to 64 years 。 Participants were randomized to receive two doses of PTX-COVID19-B (4 weeks apart [plan n = 350]) or Comirnaty (3 weeks apart [plan n = 175]) or Comirnaty® (3 weeks apart [plan n = 175]).

The primary objective of the study was to evaluate the safety and tolerability of
PTX-COVID19-B four weeks after the second dose.
Immunogenicity endpoints were measured two weeks after the second dose, including the geometric mean titer (GMT) ratio of neutralizing antibodies compared to Comirnaty® and the results
of the seroconversion rate comparison.
The final analysis of the study will include 12 months follow-up of all subjects after the first dose to assess the safety of candidate vaccines and the persistence
of immune responses.

About PTX-COVID19-B

PTX-COVID19-B is an mRNA vaccine candidate that induces potent neutralizing antibodies against the SARS-CoV-2 spike protein, thereby enhancing immune protection
against COVID-19.
PTX-COVID19-B targets the original strain of SARS-CoV-2 and prepares for
ongoing development against current and future SARS-CoV-2 variants and other multivalent β-coronavirus vaccines.

In September 2021, Genting Sun Yew signed a strategic cooperation agreement with Providence Therapeutics Holdings Inc.
("Providence") to jointly advance the research and development
of mRNA seedlings and therapeutics.
Under the terms of the agreement, Genting Sun Yew has the right to
acquire Providence's mRNA candidate in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, Thailand, Timor-Leste and Vietnam.
Genting Sun Yew has also entered into a global collaboration with Providence, under which Genting Sun Yao is able to leverage Providence's mRNA platform to develop products for drug discovery
in a wide range of other prevention and treatment areas, supported by full technology transfer related terms.