CSPC Megalith Biopharmaceutical Co., Ltd. et al. v. Shanghai Miracogen Inc. et al. - IPR2025-00685

EXPUNGED

Patent Owner's Objections to Petitioner's Evidence

Petitioner's Reply to Patent Owner's Response

Expert Declaration of Stylianos Bournazos, Ph.D,

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Chari et al., Antibody-Drug Conjugates: An Emerging Concept in Cancer Therapy,

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Crombet et al., Pharmacological Evaluation of Humanized Anti- Epidermal Growth Factor Receptor,

Vallis et al., A phase I study of 99mTc-hR3 (DiaCIM), a humanized immunoconjugate

Schechter et al., Radiation Dosimetry of 99mTc- Labeled C225 in Patients with Squamous Cell Carcinoma

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Rodríguez et al., Fc gamma receptor polymorphisms as predictive markers of Cetuximab

Bibeau et al., Impact of Fc¿RIIa-Fc¿RIIIa Polymorphisms and KRAS Mutations on the Clinical Outcome

Gerdes et al., GA201 (RG7160): A Novel, Humanized, Glycoengineered Anti-EGFR Antibody

Yi et al., Function characterization of a glyco-engineered anti-EGFR monoclonal antibody

Paz-Ares et al., Phase I Pharmacokinetic and Pharmacodynamic Dose- Escalation Study of RG7160 (GA201),

Bertino et al., Enhancement of cetuximab-induced antibody-dependent cellular cytotoxicity (ADCC)

Heimberger et al., The natural history of EGFR and EGFRvIII in glioblastoma patients,

Gan et al., The Epidermal Growth Factor Receptor Variant III (EGFRvIII):

Sampson et al., Immunologic Escape After Prolonged Progression-Free Survival with Epidermal

Van den Bent et al., Changes in the EGFR amplification and EGFRvIII expression between paired primary

ERBITUX® (cetuximab) Injection Prescribing Information (2019)

TARCEVA® (erlotinib) Tablets Prescribing Information (2010)

IRESSA® (gefitinib) Tablets Prescribing Information (2018)

Vectibix® (panitumumab) Injection Prescribing Information (2021)

Lacouture et al., Skin Toxicity Evaluation Protocol with Panitumumab (STEPP),

Kim et al., Targeting Colorectal Cancer with Human Anti-EGFR Monoclonal Antibodies:

HERCEPTIN® (trastuzumab) for Injection Prescribing Information (2024)

Stenger, Adjuvant Treatment with Ado-trastuzumab Emtansine in HER2- Positive Early Breast Cancer,

ADCETRIS® (brentuximab vedotin) Prescribing Information (2014)

Leonard et al., Phase I/II Trial of Epratuzumab (Humanized Anti-CD22 Antibody) in

Advani et al., Phase I Study of the Anti-CD22 Antibody-Drug Conjugate Pinatuzumab Vedotin

Goldstein et al., Biological Efficacy of a Chimeric Antibody to the Epidermal Growth Factor

Yang et al., Development of ABX-EGF, a Fully Human Anti-EGF Receptor Monoclonal Antibody,

Deposition Transcript of Djordje Atanackovic, M.D., April 14, 2026

Price et al., Panitumumab versus cetuximab in patients with chemotherapy-refractory

Forero-Torres et al., A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma

Wang et al., Anti-c-Met monoclonal antibody ABT-700 breaks oncogene addiction in tumors

Strickler et al., First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin,

Petitioner's Notice of Deposition of Dr. Djordje Atanackovic

Patent Owner's Unopposed Motion to Substitute Party

Assignment Record

Patent Owner's Updated Exhibit List

Signaling by Antibodies Recent Progress

Lepu Biopharma Co. Ltd. 2024 Inside Information Announcement

Use of the Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody h-R3

Bivalent binding by intermediate affinity

Dermatologic Toxicities from Monoclonal Antibodies and Tyrosine Kinase Inhibitors against EGFR

Design, Synthesis, and Biological Evaluation of Antibody-Drug Conjugates

Deposition Transcript of Dr. Stylianos Bournazos

ClinicalTrials.gov webpage for clinical trial NCT01741727

ABT-414, an Antibody–Drug Conjugate Targeting a Tumor-Selective EGFR Epitope

Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers

ClinicalTrials.gov webpage for clinical trial NCT06927986

Lepu Biopharma Global Offering

CSPC Pharmaceutical Group Limited, 2020 Annual Report

Patent Owner's Response

Declaration of Djordje Atanackovic

Patent Owner's Updated Exhibit List

Conference Transcript for Proceedings on December 2, 2025

Order Update to Scheduling Order

Email

ORDER Granting Petitioner’s Motion for Pro Hac Vice Admission of Howard S. Suh 37 C.F.R. § 42.10

Patent Owner's Notice of Deposition

Petitioners' Motion for Admission Pro Hac Vice of Howard S. Suh

Declaration of Howard S. Suh in Support of Motion for Admission Pro Hac Vice

Petitioner's Notice of Supplemental Evidence and Updated Exhibit List

Patent Owner's Objections to Evidence

Order: SCHEDULING ORDER

DECISION Granting Institution of Inter Partes Review 35 U.S.C. § 314

Director Discretionary Decision: Refer

Patent Owner's Preliminary Response

EGFR expression in normal human tissues

CD30 expression in normal human tissues

EP4434549A1

CSPC Announcement

First-in-human study of SYS6010

WO2012100346A1

Preclinical evaluation of HTI-1511

Characterization of ABBV-221

Phase I study of ABBV-321

US20110076232A1

A Study Evaluating Safety and Pharmacokinetics of ABBV-221

Lepu Biopharma Co. Ltd. 2024 Annual Report

Written Opinion of the International Searching Authority for WO2023088382

CSPC Pharmaceutical Group Ltd. Voluntary Announcement, May 19, 2025

Study of SYS6010 and Platinum-based Chemotherapy in Patients with EGFR-mutated NSCLC, April 15, 2025

Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors. Cancer.gov

Petitioners' Response to Patent Owner's Request for Discretionary Denial of Institution

Patent Owner's Request for Discretionary Denial

International Nonproprietary Names for Pharmaceutical Substances

Han et al. Becotatug Vedotin vs. Chemotherapy

Lepu Biopharma Voluntary Announcement Regarding MRG003

Fast Track _ FDA

Breakthrough Therapy _ FDA

Notice: Notice filing date accorded

Patent Owner's Mandatory Notice

Patent Owner's Power of Attorney

U.S. Patent No. 10,792,370 to Hu (“the ’370 patent”)

File History of U.S. Patent No. 10,792,370 Part 1

File History of U.S. Patent No. 10,792,370 Part 2

U.S. Patent Application Publication No. US 2015/071923 (“Wei”)

International Publication No. WO 2014/152199 (“Leanna”)

Chinese Patent Application Publication No. CN103772504 (“Liu”)

Certified English Translation of Chinese Patent App. Pub. No. CN103772504

International Publication No. WO 2015/000062 (“Tikhomirov”)

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Chinese Patent Application No. 201510085038.8 (“the ’038.8 Provisional”)

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U.S. Patent No. 9,493,568 to Reilly, et al.

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Certified English Translation of Chinese Patent App. No. 201510085038.8

Declaration of Stylianos Bournazos, Ph.D.

Petition: as filed

Notice: Power of Attorney