Evive Biotech and APOGEPHA announce collaboration to market F-627 in Germany and Switzerland

Evive Biotech (“Evive”), a global biophar­maceu­tical company deve­lo­ping novel biologic thera­pies and APOGEPHA Arznei­mittel GmbH (APOGEPHA), a Dresden based phar­maceu­tical company announce that they have entered into an exclu­sive long-term license agree­ment for the commer­cia­liza­tion of Efbe­ma­leno­gra­stim alfa (F-627) in Germany and Swit­z­er­land. F-627 is a novel dimeric G-CSF long-acting fusion protein without pegy­la­tion. Due to its unique struc­ture, the product may possess stronger G-CSF receptor activating proper­ties and improved effi­cacy compared to filgra­stim and pegfil­gra­stimi. Under the terms of the agree­ment, Evive will be respon­sible for submis­sion of the dossier and appli­ca­tion of MAA of F-627 in Germany and commu­ni­ca­tions with the Euro­pean Medi­cines Agency (EMA). Follo­wing approval of a Marke­ting Autho­riza­tion Appli­ca­tion (MAA), APOGEPHA will leverage its broad expe­ri­ences in deve­lop­ment and marke­ting in diffe­rent medical fields to consult and advice the rele­vant health care profes­sio­nals. APOGEPHA will also support Evive regar­ding addi­tional post approval studies as well as the market access process in Germany.

“We are pleased to initiate our part­nership with APOGEPHA in Germany and Swit­z­er­land, Evive’s signi­fi­cant foot­print in Europe on the commer­cia­liza­tion of F-627,” said Dr. Simon Li, CEO and CMO of Evive. Efbe­ma­leno­gra­stim alfa is a novel dimeric G-CSF fusion protein that increases the produc­tion of white blood cells (neutro­phils) to boost the immune system. It is natu­rally long-acting without the use of pegy­lated of subu­nits and is proven to be a safe and effi­ca­cious alter­na­tive to current G-CSFs, offe­ring a new hope for millions of cancer pati­ents globally. We believe APOGEPHA has the commer­cial presence and proven track record in marke­ting and sales of inno­va­tive prescrip­tion drugs and look forward to working with them to bring this novel life-chan­ging treat­ment to pati­ents in Germany and Swit­z­er­land.” Dr. Dirk Pamperin, General Manager of APOGEPHA commented: “We are very pleased to have entered into this agree­ment with Evive Biotech; the licen­sing of F-627 for Germany and Swit­z­er­land is a signi­fi­cant addi­tion to APOGE­PHA’s port­folio of diffe­ren­tiated products”. He added, Efbe­ma­leno­gra­stim alfa is an excel­lent

treat­ment option with evident bene­fits and high poten­tial to improve the therapy of cancer pati­ents signi­fi­cantly.

Evive Biotech’s MAA for F-627 (Efbe­ma­leno­gra­stim alfa) was accepted for review by EMA in September 2021. Efbe­ma­leno­gra­stim alfa is also currently under review of the FDA in US and the NMPA in China. APOGEPHA will submit the dossier with Swiss Medic in July 2022.

About F-627

F-627 (efbe­ma­leno­gra­stim alfa) is deve­l­oped for the treat­ment of chemo­the­rapy-induces neutro­penia (CIN) in cancer pati­ents after chemo­the­rapy. Neutro­penia is a common side-effect of chemo­the­rapy and is a condi­tion charac­te­rized by low levels of neutro­phils, a type of white blood cell that fights infec­tion. F-627 is a recom­bi­nant fusion protein contai­ning G-CSF at the amino terminal and human IgG2-Fc frag­ment at the carboxyl terminal. F-627 is expressed in Chinese Hamster Ovary (CHO) cells. F-627 exists as a homo­dimer with two G-CSF-Fc mole­cules cova­lently linked through disul­fide bonds formed between the Fc moiety of the mole­cule. Through specific binding to its receptor, G-CSF receptor, F-627 stimu­lates survival, proli­fe­ra­tion, diffe­ren­tia­tion, and func­tion of neutro­phil precur­sors and mature neutro­phils. F-627 streng­t­hens the immune system’s ability to fight infec­tion by incre­a­sing the produc­tion of neutro­phils, preven­ting poten­tial chemo­the­rapy dose reduc­tions and delays that may compro­mise treat­ment outcomes. The three F-627 pivotal trials are all multi-center, rando­mized, multi-dose, active-controlled study compa­ring

the effi­cacy and safety of F-627.

About Evive Biotech

Evive Biotech is a global biophar­maceu­tical company devoted to deve­lo­ping a port­folio of novel biolo­gical thera­pies for pati­ents world­wide. We leverage our proprietary tech­no­logy plat­forms to advance a series of inno­va­tive drug candi­dates for onco­logy, inflam­ma­tory and meta­bolic diseases. Founded in 2004, we currently have opera­tions in the US, Sing­a­pore, and China. As the first biophar­maceu­tical company to build a plat­form brin­ging inno­va­tive thera­pies from China to the world, Evive adopts a holistic approach to drug deve­lop­ment, combi­ning excep­tional rese­arch and commer­cia­liza­tion capa­bi­li­ties with our world-class in-house manu­fac­ture and regu­la­tory ex­per­tise as well as exten­sive inter­na­tional manage­ment expe­ri­ence. Through part­nerships with industry, physi­cians, and regu­la­tory autho­ri­ties, we strive to bring revo­lu­tio­nary reme­dies to the global markets quickly and effi­ci­ently to address unmet medical needs, making a real and lasting diffe­rence to pati­ents and their fami­lies world­wide.

About APOGEPHA Arznei­mittel GmbH APOGEPHA

Arznei­mittel GmbH is a family-owned German phar­maceu­tical company with about 150 employees and its head­quar­ters in Dresden. The company specia­lised in urology an uro-onco­logy and has long lasting expe­ri­ence as well as high ex­per­tise in in deve­lop­ment, marke­ting, and sales of inno­va­tive products. With its highly skilled sales team the company reaches Health Care Profes­sio­nals with scien­tific sound infor­ma­tion to bring best treat­ment options to pati­ents. APOGE­PHA’s products are sold in 25 markets world­wide. With F-627 APOGEPHA enlarges its port­folio in the field of onco­logy.For more company infor­ma­tion, please visit www.apogepha.com.