On November 5, 2025 BioDlink (1875.HK) reported to have congratulated its partner Lepu Biopharma (2157.HK) on receiving conditional marketing approval from China’s National Medical Products Administration (NMPA) for MEIYOUHENG (Becotatug Vedotin injection). This Class 1 innovative antibody-drug conjugate (ADC) targets the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Significantly, this is the world’s first approved non-photoimmunological EGFR-targeted ADC and a first-in-class innovation. This project is BioDlink’s first commercial ADC manufacturing initiative globally, validating its robust capabilities in the commercialization of complex biologics.

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This approval builds on BioDlink’s earlier success with Lepu Biopharma’s ADC program that achieved 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI).

The program, designated as a Breakthrough Therapy Project, required rapid tech transfer and full production line delivery from monoclonal-antibody Drug Substance through ADC Drug Product.

BioDlink’s performance in this project secured BLA approval on October 30, 2025, demonstrating its capacity to meet aggressive regulatory timelines and ensure commercial readiness for global markets.

ADC manufacturing is technologically demanding, requiring exceptional process capabilities and robust quality systems. BioDlink participated in the entire development and production cycle, from technology transfer, process development, and analytical method establishment to clinical sample and GMP-compliant commercial batch manufacturing. This reflects the company’s end-to-end capabilities in supporting complex biologics from R&D to market launch.

Through close coordination with Lepu Biopharma and multiple regulatory authorities, BioDlink established an integrated quality management system. This system ensures seamless coordination across the entire production chain—accelerate the timeline for pivotal clinical batch production and subsequent PPQto meet aggressive regulatory submission goals and aligns with global GMP standards, including those of China, the U.S., and the EU. BioDlink’s manufacturing facilities have obtained GMP certifications from several countries and Foreign Manufacturer Approval from Japan’s PMDA. This collaboration sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharma sector.

BioDlink’s manufacturing facilities have obtained GMP certifications from China, Brazil, Argentina, Indonesia, Egypt, Colombia, Pakistan and Thailand, as well as Foreign Manufacturer Approval from Japan’s PMDA. And also passed EU-QP 5 times in these years. This achievement marks a major step forward for ADC commercialization and demonstrates a practical model for multi-party industry collaboration and efficient resource integration.

Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, commented: "We sincerely thank the BioDlink team for their outstanding CDMO services and strong collaboration. This approval also establishes a practical pathway for multi-party collaboration, offering new hope for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based therapies."

Dr. Jian Zhang, Chief Operating Officer, BioDlink, noted: "The approval of this pilot batch highlights the increasing technical and quality coordination demands placed on both the Marketing Authorization Holder (MAH) and the CDMO. Moving forward, we will continue working closely with our partners to accelerate the launch of innovative medicines to benefit patients worldwide."

About Becotatug Vedotin

MEIYOUHENG (Becotatug Vedotin injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It is the world’s first approved EGFR-targeted ADC and a first-in-class innovation, for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.

(Press release, BioDlink, NOV 5, 2025, View Source [SID1234659486])

On November 5, 2025 The Parker Institute for Cancer Immunotherapy (PICI), reported that research and expertise from across its network will be showcased at the 2025 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 5–9 in National Harbor, Maryland. PICI leaders, investigators and collaborators are contributing to 80 posters, presentations and discussions throughout the 40th anniversary program – a significant presence that highlights the organization’s commitment to accelerating the development of breakthrough immune therapies for cancer.

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Notably, PICI’s President of Research, Ira Mellman, PhD, will receive SITC (Free SITC Whitepaper)’s 2025 Richard V. Smalley Memorial Award, which is given to a recognizable luminary in the field that has significantly contributed to the advancement of cancer immunotherapy research. Dr. Mellman is a distinguished cell biologist and member of the National Academy of Sciences. His pioneering work has been critical to the development of groundbreaking cancer therapies, including Tecentriq (atezolizumab), patient-specific neo-antigen mRNA and DNA vaccines, T cell-engaging bispecific antibodies and novel immunotherapies such as tiragolumab (anti-TIGIT). Dr. Mellman will receive the award and present, "The Coming Renaissance of Cancer Immunotherapy" on Saturday, November 8th (8:05-8:55 AM ET, Potomac Ballroom).

PICI CEO Karen Knudsen, MBA, PhD, will also participate in a panel discussion, "The Momentum and Future of Cancer Research Funding" on Saturday, November 8th (12:30-1:30 PM ET, Cherry Blossom Ballroom). In the session, Dr. Knudsen will join leaders from key research funding agencies that are actively shaping the cancer research landscape to discuss sustaining momentum in cancer research and funding models to accelerate discovery and drive therapeutic breakthroughs.

"The breadth of PICI science featured at SITC (Free SITC Whitepaper) this year – reflecting everything from next-gen cell therapies to applying artificial intelligence – reflects the strength of the PICI model that unites academic excellence, industry expertise, and entrepreneurial innovation," said Dr. Knudsen. "Through our investigators and portfolio companies, we are developing and accelerating access to breakthrough cancer therapies and curating innovation from discovery to commercialization, with the vision of converting all cancers to curable diseases."

Presentation Highlights from the Network

Engineering Smarter Cell Therapies
PICI investigators are redefining how engineered immune cells can safely and effectively target tumors. Through innovations like CRISPR editing, logic-gated circuits, and synthetic control of CAR and TCR activity, researchers are driving the next generation of precision cellular immunotherapies.

Primer on Tumor Immunology and Cancer Immunotherapy Workshop – Update on CAR-T cell Therapies (Pre-Conference Workshop, Thursday, November 6)
Speaker: Carl H. June, MD, Director of the PICI Center at University of Penn

UCCT-BCMA-1: A First-in-Human, Non-Viral CRISPR-Engineered CAR T Cell Therapy Targeting BCMA in Relapsed/Refractory Multiple Myeloma (Top 150Abstract 247, Poster Presentation, Friday, November 7)
Presenting author: PICI Investigator Ke Li, PhD (University of California, San Francisco)
Co-authors: PICI Investigators David Y. Oh, MD, PhD (University of California, San Francisco); Alexander Marson, MD, PhD (Gladstone Institutes); Justin Eyquem, PhD (University of California, San Francisco); Brian Shy, MD, PhD (University of California, San Francisco)

Targeting tumor-associated macrophages with CAR-Monocytes as a first-in-class approach for cellular therapy in breast cancer (Abstract 254, Oral Presentation, Young Investigator Award, Saturday, November 8)
Co-author: PICI Investigator Rizwan Romee, MD (Dana-Farber Cancer Institute)

Engineered T cell therapy combined with PD-1, Lag-3 and Tim-3 checkpoint inhibition promotes pro-inflammatory CD4 T cell differentiation in an ovarian cancer mouse model (Abstract 339, Poster Presentation, Friday, November 7)
Co-author: PICI Investigator Philip D. Greenberg, MD (Fred Hutchinson Cancer Center)

Discovery and characterization of human T cell receptors that recognize tumor-associated antigens derived from tumor suppressors p16INK4A and p14ARF ( Abstract 345 , Poster Presentation, Friday, November 7)
Co-author: PICI Investigator Philip D. Greenberg, MD (Fred Hutchinson Cancer Center)

Tuning CAR-T cells by targeting cancer-associated glycan in pancreatic cancer; Augmenting Notch1 to enhance CD19-BBz CAR-T therapy (Abstract 262, Poster Presentation, Saturday, November 8)
Co-author: PICI Extramural Researcher Marcela Maus, MD, PhD (Massachusetts General Hospital)

AB-3028: Dual-targeting sequential AND logic gated CAR T cell for potential mCRPC therapeutic; Programmable Circuit T cells encoding multiplexed shRNAs and logic-gates for mCRPC (Abstract 303, Poster Presentation, Friday, November 7)
Presenting author: PICI Portfolio Company ArsenalBio
Artificial Intelligence and Machine Learning Driving Discovery
From tumor profiling to CAR-T optimization, AI is accelerating discovery and decision-making in immuno-oncology. PICI researchers are leveraging multimodal data and large language models to predict toxicity, design smarter therapies, and redefine how data informs innovation.

Leveraging the Power of Artificial Intelligence to Foster Progress in Immuno-oncology: Opportunities and Challenge – A Post-Data World – LLMs and the End of Data Paralysis (Pre-Conference Workshop, Thursday, November 6)
Speaker: PICI Investigator Garry P. Nolan, PhD (Stanford Medicine)

Rational CAR T cell design via attention-based multiple instance learning of infusion product scRNA-seq data (Abstract 1126, Poster Presentation, Saturday, November 8)
Co-authors: PICI Investigators Crystal L. Mackall, MD (Stanford Medicine); David Miklos, MD, PhD (Stanford Medicine); Zinaida Good, PhD (Stanford Medicine)

A Pan-Cancer Single-Cell Multimodal Atlas of Antigen-Specific T Cells and Scalable Framework for Mapping Antigen Specificity (Top 150,Abstract 1112, Oral Presentation, Young Investigator Award, Saturday, November 8)
Co-author: PICI Investigator Roberta Zappasodi, PhD (Weill Cornell Medicine)

Pre-treatment predictive modeling of immune-related adverse event risk in immune checkpoint blockade therapy: A multi-modal machine learning approach from a real-world setting – RADIOHEAD Cohort Study (Abstract 1094, Poster Presentation, Saturday, November 8)
Co-authors: PICI Chief Scientific Officer John Connolly, PhD; PICI Research Director EnJun Yang, PhD

gx1: Virtual Target Identification for Overcoming T Cell Exhaustion (Abstract 1125, Poster Presentation, Friday, November 7)
Presenting author: PICI Portfolio Company ArsenalBio

(Press release, Parker Institute for Cancer Immunotherapy, NOV 5, 2025, View Source [SID1234659485])

On November 5, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate and present at the following investor conferences in November:

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Guggenheim Healthcare Conference 2025: Fireside chat on Tuesday, November 11 at 1:00 pm ET
Jefferies Global Healthcare Conference in London: Fireside chat on Wednesday, November 19 at 2:30 pm GMT (9:30 am ET)
A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

(Press release, Verastem, NOV 5, 2025, View Source [SID1234659483])

On November 5, 2025 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, reported that members of the Company’s management team will participate and be available for one-on-one meetings at the following investor conferences:

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Stifel 2025 Healthcare Conference
Wednesday, November 12, 2025
Fireside Chat at 10:00 a.m. ET
Jefferies Global Healthcare Conference
Thursday, November 20, 2025
Fireside Chat at 9:30 a.m. GMT
The sessions will be webcast and can be accessed by visiting the Events section of the Altimmune website.

(Press release, Altimmune, NOV 5, 2025, View Source [SID1234659482])

On November 5, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the third quarter ended September 30, 2025 and provided recent business and clinical program updates.

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"Xencor’s two novel, first-in-class, CD3 T-cell engaging bispecific antibodies, XmAb819 and XmAb541, have demonstrated compelling clinical data in advanced clear cell renal cell carcinoma and advanced gynecologic and germ cell tumors, respectively. As we continue to advance through dose escalation and cohort expansions in Phase 1 studies evaluating these programs, we expect to identify recommended Phase 3 doses during 2026 to support initiation of pivotal studies during 2027," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "The accelerating tempo of clinical development extends to our autoimmune portfolio. In the third quarter we dosed the first patient in our Phase 2b XENITH-UC study of XmAb942, our potential best-in-class antibody targeting TL1A for inflammatory bowel disease, to rapidly identify a pivotal dose regimen for those with moderately to severely active ulcerative colitis, and we dosed the first patient in our Phase 1b study of plamotamab in rheumatoid arthritis. We remain on-track to start clinical studies of XmAb657, our B-cell depleting TCE for the treatment of patients with autoimmune disease by year end 2025, and our lead TL1A x IL23p19 bispecific antibody, now designated XmAb412, in 2026."

Clinical Program Updates

Oncology

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). The first dose-expansion cohort in the ongoing Phase 1 study is enrolling patients as dose-escalation continues. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study in advanced ccRCC during 2027.

At the AACR (Free AACR Whitepaper)-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in October 2025, Xencor presented initial results from the ongoing Phase 1 dose-escalation study of XmAb819. As of the data cut-off, 69 patients had received XmAb819 across 15 dose cohorts; patients were heavily pre-treated, having received a median of 4 prior lines of therapy. All patients received prior anti-PD1 therapy and prior VEGF-TKI therapy, and 36% of patients were previously treated with a HIF2α inhibitor. XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated across dose levels. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (PR, per RECIST v1.1) as best response with a 70% disease control rate. The most common treatment-emergent adverse events (AEs) were cytokine release syndrome, rash and gastrointestinal-related toxicities that were primarily Grade 1 or 2 in severity and predominantly associated with prime-step dosing in the first four weeks of treatment. No cases of treatment-related immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. No Grade 5 events were reported. Four patients (6%) were dose-reduced due to treatment-related AEs, and three patients (4%) discontinued treatment due to treatment-related AEs.
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study during 2027.

In October 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541, ahead of previously guided timelines to begin characterizing target dose range cohorts by year-end 2025. As of the data cut-off, nine patients received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses per RECIST v1.1 were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors.
Autoimmune & Inflammatory Diseases

Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in a Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. The first patient has been dosed in the study, and enrollment is ongoing.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Patient enrollment in the study is ongoing.
Recent Partnership Developments

Amgen: Amgen initiated the Phase 3 XALience study of xaluritamig, a STEAP1 x CD3 XmAb 2+1 bispecific T-cell engager, in combination with abiraterone versus investigator’s choice therapy in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer. XALute, a Phase 3 monotherapy study of xaluritamig in patients who have previously been treated with taxane-based chemotherapy, is enrolling. Amgen is exploring xaluritamig in other combinations and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Xencor is eligible to receive $225 million in future milestone payments and tiered royalties on net sales that range from mid- to high-single digit percentages.
Astellas: In October 2025, the first clinical data from Astellas’ investigational Claudin18.2-targeted, XmAb 2+1 bispecific CD3 T-cell engager, ASP2138, both as a monotherapy and in combination with standard of care therapies, were presented during the European Society for Medical Oncology congress in Berlin. Astellas is advancing ASP2138 for the treatment of patients with gastric, gastroesophageal junction and pancreatic cancers, and Astellas has announced that planning is ongoing to potentially initiate registrational studies. ASP2138 utilizes the XmAb 2+1 multivalent format to enable activation of T cells against Claudin-18.2 expressing tumor cells. Xencor is eligible to receive $232.5 million in future milestone payments and tiered royalties on net sales that range from high-single to low-double digit percentages.
Zenas Biopharma: In October 2025, Zenas announced positive results from the Phase 2 MoonStone trial of obexelimab in relapsing multiple sclerosis, in which the primary endpoint of the study was met. Zenas announced it expects to report topline results for the pivotal study of obexelimab in IgG4-Related Disease around year-end with additional readouts through mid-2026. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas. Xencor is eligible to receive $460 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography. As of September 30, 2025, Xencor owns 3,098,380 shares of common stock in Zenas.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $570 million and $590 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the Third Quarter Ended September 30, 2025

Cash, cash equivalents and marketable debt securities totaled $633.9 million as of September 30, 2025, compared to $706.7 million as of December 31, 2024.

Revenue for the third quarter ended September 30, 2025 was $21.0 million, compared to $17.8 million for the same period in 2024. Revenue earned in the third quarters of 2025 and 2024 was primarily non-cash royalty revenue from Alexion and Incyte.

Research and development (R&D) expenses for the third quarter ended September 30, 2025 were $54.4 million, compared to $58.2 million for the same period in 2024. Decreased R&D spending for the third quarter of 2025 compared to 2024 reflects lower stock-based compensation and lower costs related to programs that are winding down or have been terminated.

General and administrative (G&A) expenses for the third quarter ended September 30, 2025 were $14.2 million, compared to $14.8 million for the same period in 2024. G&A spending for the third quarter of 2025 remained relatively consistent compared to the same period in 2024.

Other income, net, for the third quarter ended September 30, 2025 was $41.5 million, compared to $7.8 million for the same period in 2024. The increase for the third quarter of 2025, compared to 2024, is primarily driven by unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the third quarter ended September 30, 2025 was $6.0 million, or $(0.08) on a fully diluted per share basis, compared to net loss of $46.3 million, or $(0.72) on a fully diluted per share basis, for the same period in 2024.

(Press release, Xencor, NOV 5, 2025, View Source [SID1234659480])