Planegg / Munich, Germany, and Shanghai, China (Press Release) – MorphoSys AG (FSE:MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ:MOR) and I-Mab Bio­pharma­ (I-Mab) announced today that I-Mab has received Inves­ti­ga­tional New Drug (IND) clear­ances from the National Medical Products Admin­istra­tion (NMPA) of China to ex­pand the ongoing phase 2 and 3 clin­i­cal trials of MOR202 / TJ202, MorphoSys's human mono­clonal anti-CD38 anti­body for the treat­ment of multiple myeloma (MM), also to mainland China. I-Mab, a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany exclusively focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases, owns the exclusive rights for devel­op­ment and com­mer­cial­iza­tion of MOR202 / TJ202 in China, Taiwan, Hong Kong and Macao.

I-Mab is cur­rently conducting two clin­i­cal trials with MOR202 / TJ202 in Taiwan. The phase 2 study, which was ini­ti­ated in March 2019, is designed to eval­u­ate the efficacy and safety of MOR202 / TJ202 as third-line treat­ment in patients with re­lapsed or re­frac­tory (r/r) MM. The phase 3 study, ini­ti­ated in April 2019, assesses the efficacy and safety of the com­bi­na­tion of MOR202 / TJ202 plus lena­lido­mide (LEN) and dexa­meth­a­sone (DEX) versus the com­bi­na­tion of LEN and DEX in patients with re­lapsed or re­frac­tory MM who received at least one prior line of treat­ment. Under the fast-to-market devel­op­ment strat­e­gy, I-Mab will now be ex­panding these trials into mainland China.

"Receiving two IND clear­ances for MOR202 / TJ202 from the China NMPA marks an im­por­tant mile­stone for us and dem­onstrates I-Mab's capability and commitment to the ad­vancement of immun­o­log­i­cal tech­nology for the mar­ket. We will move for­ward with the clin­i­cal devel­op­ment of MOR202 / TJ202 in China to bring it to the mar­ket as efficiently as possible. I-Mab will con­tinue to ex­pand our port­folio in inno­va­tive thera­peutics to benefit patients in need," commented Dr. Jingwu Zang, MD., PhD., Founder and Chairman of I-Mab Bio­pharma­.

"We are very pleased that our partner I-Mab now also received the IND clear­ances for MOR202 / TJ202 for China, allow­ing the ex­pan­sion of the clin­i­cal devel­op­ment of the anti­body in r/r multiple myeloma to this region," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "There is a high need for alter­na­tive treat­ment options for patients with r/r multiple myeloma in the Chinese region and we look for­ward to the further devel­op­ment of MOR202 / TJ202 by our partner I-Mab in this in­di­ca­tion."

About MOR202 / TJ202

MOR202/TJ202 is an inves­ti­ga­tional human mono­clonal anti­body derived from MorphoSys's HuCAL anti­body tech­nology. The anti­body is directed against CD38 on the surface of multiple myeloma cells, which has been char­ac­ter­ized as one of the most strongly and uniformly ex­pressed an­ti­gens on the surface of malignant plasma cells. According to its sug­gested mode of action, the anti­body recruits cells of the body's immune sys­tem to kill the tumor through anti­body-dependent cellular cyto­tox­icity (ADCC) and anti­body-dependent cellular phago­cytosis (ADCP). The anti­body does not in­volve­ com­ple­ment dependent cyto­tox­icity, or CDC, an addi­tional immune mech­a­nism in­volve­d in tumor cell killing. Scientific research sug­gests that an anti-CD38 anti­body may have thera­peutic poten­tial also in other cancers as well as auto­immune dis­eases. Based on a licensing agree­ment be­tween MorphoSys and I-Mab signed in No­vem­ber 2017, I-Mab owns the exclusive rights for devel­op­ment and com­mer­cial­iza­tion of MOR202 / TJ202 in mainland China, Taiwan, Hong Kong and Macao.

About I-Mab Bio­pharma­

I-Mab is a dynamic and fast-growing bio­tech com­pany exclusively focused on devel­op­ing novel or highly dif­fer­en­ti­ated biologics in the thera­peutic areas of immuno-oncology and auto­immune dis­eases. I-Mab's mission is to bring transformational med­i­cines to patients through inno­va­tion. I-Mab's inno­va­tive pipe­line of more than 10 clin­i­cal and pre-clinical stage drug can­di­dates is driven by the Com­pany's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market devel­op­ment strategies through internal R&D and global part­ner­ships. The Com­pany is on track to be­come a fully integrated end-to-end global bio­pharma­ceu­tical com­pany with cutting-edge discovery plat­forms, proven pre­clin­i­cal and clin­i­cal devel­op­ment ex­per­tise, and world-class GMP manu­fac­tur­ing capabilities. I-Mab is well-recognized by capital mar­kets to have suc­cess­fully raised over US $400 million in equity financing since its estab­lish­ment in 2016. Its recent US $200 million Series C financing rep­re­sents one of the largest amounts ever raised by a bio­tech com­pany in China, as stated by I-Mab. For more in­for­ma­tion, please see the Com­pany's website at http://www.i-mabbiopharma.com/en/.

About MorphoSys

MorphoSys (FSE & NASDAQ: MOR) is a clin­i­cal-stage bio­pharma­ceu­tical com­pany dedicated to the discovery, devel­op­ment and com­mer­cial­iza­tion of exceptional, inno­va­tive ther­a­pies for patients suffer­ing from serious dis­eases. The focus is on cancer. Based on its leading ex­per­tise in anti­body, protein and peptide tech­nolo­gies, MorphoSys, together with its partners, has devel­oped and con­trib­uted to the devel­op­ment of more than 100 prod­uct can­di­dates, of which 29 are cur­rently in clin­i­cal devel­op­ment. In 2017, Tremfya(R), mar­keted by Janssen for the treat­ment of plaque psoriasis, became the first drug based on MorphoSys's anti­body tech­nology to receive regu­la­tory approval. The Com­pany's most ad­vanced pro­pri­e­tary prod­uct can­di­date, tafasitamab (MOR208), has been granted U.S. FDA break­­through ther­apy desig­na­tion for the treat­ment of patients with re­lapsed / re­frac­tory diffuse large B-cell lym­phoma (DLBCL). Headquartered near Munich, Germany, the MorphoSys group, in­clud­ing the fully owned U.S. sub­sid­i­ary MorphoSys US Inc., has approx­i­mately 370 employees. More in­for­ma­tion at https://www.morphosys.com.

HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high poten­tials(R), Slonomics(R), Lanthio Pharma(R), LanthioPep(R) and ENFORCERTM are trademarks of the MorphoSys Group. Tremfya(R) is a trademark of Janssen Biotech, Inc.

MorphoSys for­ward looking state­ments

This communication con­tains cer­tain for­ward-looking state­ments con­cern­ing the MorphoSys group of com­pa­nies, in­clud­ing the ex­pec­ta­tions re­gard­ing the ex­pan­sion of the ongoing phase 2 and phase 3 clin­i­cal studies to eval­u­ate MorphoSys's inves­ti­ga­tional CD38 anti­body MOR202 / TJ202 in com­bi­na­tion with lena­lido­mide in patients with re­lapsed or re­frac­tory multiple myeloma to mainland China as well as the size and scope of these studies, ex­pec­ta­tions in connection with MOR202 / TJ202 and ex­pec­ta­tions re­gard­ing the further devel­op­ment of MOR202 / TJ202 in multiple myeloma in Greater China, in­clud­ing the in­tended targeting of CD38 and the sug­gested mode of action, poten­tial addi­tional in­di­ca­tions such as auto­immune dis­eases, as well as ex­pec­ta­tions re­gard­ing a poten­tial future regu­la­tory filing for MOR202 / TJ202. The for­ward-looking state­ments con­tained herein rep­re­sent the judg­ment of MorphoSys as of the date of this release and in­volve­ known and unknown risks and un­cer­tainties, which might cause the actual results, financial con­di­tion and liquidity, per­for­mance or achieve­ments of MorphoSys, or industry results, to be ma­teri­ally dif­fer­en­t from any historic or future results, financial con­di­tions and liquidity, per­for­mance or achieve­ments ex­pressed or implied by such for­ward-looking state­ments. In addi­tion, even if MorphoSys' results, per­for­mance, financial con­di­tion and liquidity, and the devel­op­ment of the industry in which it operates are con­sis­tent with such for­ward-looking state­ments, they may not be predictive of results or devel­op­ments in future periods. Among the factors that may result in dif­fer­ences are MorphoSys' ex­pec­ta­tions re­gard­ing re­gard­ing the ex­pan­sion of the ongoing phase 2 and phase 3 clin­i­cal studies to eval­u­ate MorphoSys's inves­ti­ga­tional CD38 anti­body MOR202 / TJ202 in com­bi­na­tion with lena­lido­mide in patients with re­lapsed or re­frac­tory multiple myeloma to mainland China as well as the size and scope of this studies, ex­pec­ta­tions in connection with MOR202 / TJ202 and ex­pec­ta­tions re­gard­ing the further devel­op­ment of MOR202 / TJ202 in multiple myeloma in Greater China, in­clud­ing the in­tended targeting of CD38 and the sug­gested mode of action, poten­tial addi­tional in­di­ca­tions such as auto­immune dis­eases, as well as ex­pec­ta­tions re­gard­ing a poten­tial future regu­la­tory filing for MOR202 / TJ202, MorphoSys' reliance on col­lab­o­rations with third parties, estimating the commercial poten­tial of its devel­op­ment pro­grams and other risks in­di­cated in the risk factors in­cluded in MorphoSys's Annual Report on Form 20-F and other filings with the US Se­cu­ri­ties and Exchange Com­mis­sion. Given these un­cer­tainties, the reader is advised not to place any undue reliance on such for­ward-looking state­ments. These for­ward-looking state­ments speak only as of the date of publication of this document. MorphoSys expressly disclaims any obli­ga­tion to update any such for­ward-looking state­ments in this document to reflect any change in its ex­pec­ta­tions with regard thereto or any change in events, con­di­tions or cir­cum­stances on which any such state­ment is based or that may affect the likelihood that actual results will differ from those set forth in the for­ward-looking state­ments, unless specifically required by law or reg­u­la­tion.

Source: MorphoSys.