Zhi­meng Bio­phar­ma An­nounces the First-in-Hu­man Dos­ing in Phase I Clin­i­cal Tri­al of ZM-H1505R De­signed for the Treat­ment of Chron­ic He­pati­tis B Virus In­fec­tion

Shang­hai – March 5, 2020. — Zhi­meng Bio­phar­ma, Inc to­day an­nounced the ini­ti­a­tion of the first-in-hu­man dos­ing of ZM-H1505R in its Phase I clin­i­cal study in the Unit­ed States. ZM-H1505R is a nov­el, in­ves­ti­ga­tion­al HBV cap­sid for­ma­tion in­hibitor that is be­ing de­vel­oped by Zhi­meng Bio­phar­ma for the treat­ment of chron­ic HBV in­fec­tion. Pri­ma­ry re­sults showed that the drug is safe and well tol­er­at­ed in health vol­un­teers test­ed.

The cur­rent Phase I clin­i­cal tri­al of ZM-H1505R in the Unit­ed States is a ran­dom­ized, dou­ble-blind, place­bo-con­trolled se­quen­tial sin­gle and mul­ti­ple as­cend­ing dose (SAD/MAD) study fol­low­ing oral ad­min­is­tra­tion in healthy sub­jects to eval­u­ate the safe­ty, tol­er­a­bil­i­ty, and phar­ma­co­ki­net­ics of ZM-H1505R. Zhi­meng an­tic­i­pates the full re­sults from this study to be re­leased by the third quar­ter of this year. Im­me­di­ate­ly fol­low­ing this tri­al, the clin­i­cal study of ZM-H1505R in Chi­na with HBV-in­fect­ed pa­tients will be con­duct­ed lat­er this year.

Dif­fer­ent from the re­port­ed Type I and Type II HBV core pro­tein al­losteric mod­u­la­tors (CpAMs), ZM-H1505R is a nov­el pyra­zole mol­e­cule that has a new bind­ing site in the HBV core pro­tein. It in­hibits HBV repli­ca­tion by hin­der­ing the pack­ag­ing of pre-ge­nom­ic RNA (pgR­NA) in­to the vi­ral cap­sid and by block­ing the for­ma­tion of HBV co­va­lent­ly closed cir­cu­lar DNA (cc­cD­NA).

“The first-in-hu­man dos­ing of ZM-H1505R in the Unit­ed States is a key step for­ward in our pur­suit of a func­tion­al cure for chron­ic HBV in­fec­tion. It is al­so an im­por­tant mile­stone for Zhi­meng, as it marks our tran­si­tion to a clin­i­cal-stage com­pa­ny,” said Huan­ming Chen, Ph.D., Chief Ex­ec­u­tive Of­fi­cer of Zhi­meng Bio­phar­ma. “Cur­rent­ly there are about 250 mil­lion peo­ple world­wide chron­i­cal­ly in­fect­ed by HBV and near­ly one mil­lion peo­ple die from HBV-re­lat­ed liv­er dis­eases each year. Cur­rent treat­ments rarely cure the HBV in­fec­tion and the drugs have to be tak­en for life. It is clear that there is a sig­nif­i­cant­ly un­met need for new drugs for HBV in­fec­tion. We are ex­cit­ed that the ZM-H1505R-101 clin­i­cal tri­al is un­der­way and hope­ful that ZM-H1505R has the po­ten­tial to be­come a crit­i­cal com­po­nent of a cur­ing reg­i­men for chron­ic HBV in­fec­tion”.

For more in­for­ma­tion about the ZM-H1505R-101 clin­i­cal study, please vis­it clin­i­cal­tri­als.gov and use the iden­ti­fi­er NCT04220801.

About Chron­ic He­pati­tis B Virus (HBV) In­fec­tion

Ac­cord­ing to an es­ti­mate by the World Health Or­ga­ni­za­tion, HBV is the lead­ing cause of the world’s most com­mon and se­ri­ous liv­er in­fec­tion, with more than 240 mil­lion peo­ple chron­i­cal­ly in­fect­ed, and ap­prox­i­mate­ly 780,000 deaths from HBV-in­fect­ed dis­eases. In Chi­na alone, rough­ly 90 mil­lion peo­ple are chron­i­cal­ly in­fect­ed by HBV, and among those af­fect­ed, 30 mil­lion are in need of chron­ic treat­ment.

About Zhi­meng Bio­phar­ma, Inc.

Found­ed in 2017, Zhi­meng Bio­phar­ma’s drug dis­cov­ery and de­vel­op­ment falls in­to two ther­a­peu­tic ar­eas: chron­ic he­pati­tis B virus in­fec­tion and cen­tral ner­vous dis­ease. The com­pa­ny strives to de­vel­op in­no­v­a­tive drugs to treat chron­ic he­pati­tis B, stroke, epilep­sy, and oth­er ar­eas of neu­ro­log­i­cal dis­eases. Most of Zhi­meng’s prod­ucts will be ready for clin­i­cal eval­u­a­tion in 2021. ZM-H1505R is one of in­no­v­a­tive prod­ucts in Zhi­meng’s HBV pipeline. In Jan­u­ary 2020, the com­pa­ny an­nounced the ap­proval of its IND from US FDA for start­ing clin­i­cal tri­al on ZM-H1505R.

For­ward-Look­ing State­ments

This press re­lease con­tains for­ward-look­ing state­ments. Such state­ments are sub­ject to risks and un­cer­tain­ties that could cause ac­tu­al per­for­mance and re­sults to dif­fer ma­te­ri­al­ly from any pro­jec­tions of fu­ture per­for­mance or re­sult ex­pressed or im­plied by such for­ward-look­ing state­ments. Ex­cept for state­ments of known facts, in­for­ma­tion con­tained here­in con­tains for­ward-look­ing state­ments re­gard­ing, among oth­ers, (i) the ther­a­peu­tic and com­mer­cial po­ten­tial of ZM-H1505R and Zhi­meng’s oth­er prod­ucts in pipelines; and (ii) the re­search and de­vel­op­ment plans and time­lines re­lat­ed to ZM-H1505R and Zhi­meng’s oth­er prod­ucts in pipelines. The read­ers are ad­vised that the process by which an ear­ly stage in­ves­ti­ga­tion­al ther­a­py such as ZM-H1505R could po­ten­tial­ly be­come an ap­proved drug is long and in­volves sig­nif­i­cant risks and un­cer­tain­ties. These risks and un­cer­tain­ties in­clude, among oth­ers, the cost, tim­ing and re­sults of pre­clin­i­cal stud­ies and clin­i­cal tri­als and oth­er de­vel­op­ment ac­tiv­i­ties; the un­pre­dictabil­i­ty of the du­ra­tion and out­comes of reg­u­la­to­ry re­views of IND Ap­pli­ca­tion and New Drug Ap­pli­ca­tion; mar­ket ac­cep­tance of new­ly ap­proved prod­ucts and treat­ments; and com­pe­ti­tion. The for­ward-look­ing state­ments con­tained in this press re­lease re­flect Zhi­meng’s cur­rent views with re­spect to fu­ture events. Zhi­meng un­der­takes no oblig­a­tion to up­date for­ward-look­ing state­ments if cir­cum­stances or com­pa­ny’s es­ti­mates or opin­ions should change ex­cept as re­quired by ap­plic­a­ble laws. The read­ers are cau­tioned not to place un­due re­liance on for­ward-look­ing state­ments.

Shang­hai Zhi­meng Bio­phar­ma, Inc.
Rong Peng, Ph.D.
+86 21 50391670