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Medicilon and Hailu Biotech of Yangtze River Pharmaceutical Group Forge Strategic Cooperation to Accelerate New Drug R&D and Global Outreach

On March 30, 2026 Medicilon reported a strategic cooperation signing ceremony with Suzhou Hailu Biotech, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group. The collaboration will focus on deepening synergy in preclinical new drug R&D, project introduction, and global market expansion, with the goal of jointly building an efficient, open, and international R&D ecosystem spanning from source innovation to IND filing. This partnership is poised to lead the high-quality development and global advancement of China’s biomedical industry.

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Key executives from both organizations attended the ceremony and engaged in in-depth discussions on the cooperation’s vision and implementation roadmap. Representatives from Yangtze River Pharmaceutical Group included Ruwei Wang, Special Assistant to the Chairman and Head of the Group’s Pharmaceutical Research Institute; Jian Liu, Assistant to the Dean and Head of the Macromolecule Innovation Center; and Wenjun Shan, Head of the Small Molecule Innovation Center. From Medicilon, attendees included Chunlin Chen, Chairman and CEO; Jinna Cai, Director and Chief Business Officer; Guokai Chen, Director and Vice President of Investment & Financing; Jian Ge, Executive Vice President of the Preclinical Division; and Binbin Liu, Vice President of Operations.

Complementary Strengths to Accelerate One-Stop New Drug R&D

As a core biologic R&D platform and wholly-owned subsidiary of Yangtze River Pharmaceutical Group, Hailu Biotech has established a comprehensive macromolecule innovative drug R&D system covering target discovery, molecular design, and preclinical development. Leveraging its antibody discovery and engineering platforms, Hailu Biotech focuses on cutting-edge technologies such as monoclonal/bispecific antibodies, ADCs, and small nucleic acids, with a focus on oncology, metabolism, autoimmune diseases, and central nervous system disorders. The company is committed to addressing unmet clinical needs and delivering improved treatment options for patients through its leading technological capabilities.

Medicilon, a leading one-stop preclinical R&D CRO, offers end-to-end services spanning drug discovery, pharmaceutical research, and preclinical studies. The company operates a research system compliant with standards set by China’s NMPA, the U.S. FDA, OECD GLP, and AAALAC accreditation. Medicilon has also built specialized R&D service platforms for novel molecular drugs, including antibodies, ADCs, mRNA vaccines, small nucleic acids, PROTACs, and CGT. With a track record of mature technological platforms and successful cases, Medicilon has supported the global launch of multiple innovative drugs.

16 Years of Collaboration: From Project Partnership to Strategic Symbiosis
This strategic cooperation builds on a long-standing partnership between the two parties, which dates back to 2010. Over the past 16 years, Medicilon has established long-term cooperative relationships with Yangtze River Pharmaceutical Group and its subsidiaries, including Shanghai Haiyan Pharmaceutical Technology, Shanghai Hailu Biotechnology, Shanghai Haini Pharmaceutical, Nanjing Hailing Pharmaceutical, Guangzhou Hairui Pharmaceutical. Its services cover the entire preclinical R&D chain, encompassing small nucleic acids, small-molecule chemical drugs, and traditional Chinese medicines, empowering nearly 100 new drug R&D projects and supporting the approval and launch of key drugs such as Dezocine Injection, Omeprazole Enteric-coated Capsules, Levofloxacin Eye Drops, Ticagrelor Tablets, and Tacrolimus.

Shared R&D philosophies, aligned technical services, and consistent quality systems have fostered a mature and efficient collaboration mechanism between the two parties. This foundation of trust and business synergy has elevated their partnership from project-level cooperation to a strategic win-win alliance. Moving forward, the two parties will conduct customized R&D collaboration through flexible models such as commissioned R&D, FTE and FFS, covering one-stop preclinical services including early drug discovery, in vitro and in vivo efficacy studies, Chemistry, CMC, pharmacokinetics, safety evaluation, and regulatory registration. This integration will enable seamless process connection and efficient utilization of R&D resources.

"Bring In & Go Global": Building a Two-Way Ecosystem for Global Drug Outreach
In terms of business development, the two parties will jointly build a "bring in and go global" ecosystem to facilitate the integration of Chinese innovative drugs into the global market, featuring two-way empowerment and mutual promotion. To support global outreach, Medicilon will leverage its mature international platform and global network to connect Hailu Biotech with overseas partners, showcase innovative achievements through participation in top global industry conferences, and accelerate the overseas licensing and development of Hailu Biotech’s drug pipeline.
Meanwhile, Medicilon will use its international perspective and project resources to link Yangtze River Pharmaceutical Group with high-quality overseas innovative drug pipelines and targets, facilitating their development and equity cooperation in the Chinese market. Beyond accelerating the internationalization of individual projects, this ecosystem aims to create a sustainable two-way flow of technologies, resources, and markets, enhancing the global visibility and competitiveness of Chinese innovative drugs.

(Press release, Shanghai Medicilon, MAR 30, 2026, View Source [SID1234664154])

INmune Bio Inc. Announces 2025 Results and Provides Business Update

On March 30, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, reported its financial results for the year ended December 31, 2025 and provides a business update.

Recent Corporate Highlights

CORDStrom Platform:

The CORDStrom program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom in patients with RDEB.
Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy.
XPro Platform:

Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro in early Alzheimer’s Disease.
Hosted expert-led webinar on XPro registrational study strategy for early Alzheimer’s Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.
INKmune Platform:

Met primary and two of three secondary endpoints in CARE-PC trial
Continued evaluation of clinical data from the INKmune CARE-PC trial in metastatic castration-resistant prostate cancer.
Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
Corporate:

Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026.
Company estimates that cash on hand provides runway through Q1 of 2027.
During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million.
Continued alignment of capital allocation with clinical development priorities.
Upcoming Events and Milestones:

The Marketing Authorization Application (MAA) for CORDStrom is scheduled for submission to the UK’s MHRA in mid-summer, followed directly by an EMA filing.
CORDStrom Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
"Reflecting on the progress of 2025 and the momentum of early 2026, it is clear that INmune Bio has reached a defining inflection point," said David Moss, CEO of INmune Bio. "We have transitioned from a mid-stage clinical company into a late-stage, registration-directed organization. Our mission to harness the innate immune system to treat diseases of inflammation has never been more tangible or more urgent. Looking ahead through 2026 and 2027, our strategy is anchored by two late-stage assets that represent significant value for both patients and shareholders: CORDStrom and XPro."

CORDStrom: A Clear Path to Commercialization

CORDStrom, our mesenchymal stromal cell platform for Recessive Dystrophic Epidermolysis Bullosa, is our most immediate commercial catalyst.

2026 Regulatory Milestones: In February, we formally submitted our pre-submission package to the UK’s MHRA. A face-to-face meeting with the MHRA is scheduled for mid-May. We remain on track to file our first Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by EU and U.S. (BLA) filings in Q4.
Operational Readiness: We have successfully completed three commercial pilot-scale manufacturing runs at our Stevenage facility, meeting all release criteria. This ensures we are ready to supply the market upon approval.
Financial Strategy: With the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through 2029, CORDStrom offers a dual-value proposition: a life-changing therapy for "butterfly children" and a high-value PRV that can be monetized to non-dilutively fund our long-term operations.
XPro: Redefining the Alzheimer’s Paradigm

The landscape of Alzheimer’s disease (AD) is shifting toward precision medicine, and INmune Bio is at the forefront.

2026 Focus: Following our successful End-of-Phase 2 meeting with the FDA in February, we have achieved alignment on an integrated Phase 2b/3 registrational pathway. Unlike traditional "all-comer" trials, our program uses a biomarker-enriched design, targeting patients with neuroinflammation. This "precision" approach, validated by our MINDFuL trial data featured at the AD/PD 2026 Plenary, significantly de-risks our path forward.
2027 Horizon: Our Phase 2b/3 program is built to bridge the gap between early cognitive signals (EMACC) and late-stage functional outcomes (CDR-SB). The Phase 2b stage evaluates co-primary endpoints at nine months and serves as a clearly powered go or no-go before we commit to the full Phase 3 registrational portion of the trial. If EMACC and/or pTau-217 readout successfully in the Phase 2b portion of the trial, it advances seamlessly into the registrational stage Phase 3 with CDR-SB at eighteen months (the same primary endpoint used to approve lecanemab and donanemab). The scientific basis for this design is well established: cognitive changes (EMACC) precede and predict functional decline (CDR-SB), which means early cognitive signals at nine months support confidence in functional outcomes at eighteen. We believe this program represents a compelling partnership opportunity, while remaining a viable path for independent development following CORDStrom approval, assuming favorable capital conditions.
Notably, XPro has reported zero cases of ARIA across all clinical studies to date, a critical differentiator in a treatment landscape where ARIA remains a significant limitation of approved therapies.

"From a capital perspective, we remain committed to capital efficiency," said Mr. Moss. "Our strategy is built on hitting clear, data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We are focused on maintaining the lean, execution-oriented culture that has brought us to this stage."

"2026 is the year of filings and preparation; 2027 will be the year of pivotal execution and potential launch. We thank you for your continued trust and partnership as we work to transform the treatment of inflammatory disease."

Financial Results for the Year Ended December 31, 2025

Net loss attributable to common stockholders for the year ending December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million during the year ended December 31, 2024.
Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared to approximately $33.2 million during the year ended December 31, 2024.
General and administrative expenses were approximately $10.3 million for the year ended December 31, 2025, compared to approximately $9.5 million during the year ended December 31, 2024.
Impairment of acquired in-process research and development intangibles assets was $16.5 million during the year ended December 31, 2025, compared to $0 during the year ended December 31, 2024.
As of December 31, 2025, the Company had cash and cash equivalents of approximately $24.8 million.
As of December 31, 2025, the Company had approximately 26.6 million common shares outstanding.
Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter and Full Year Ended December 31, 2025 Conference Call when reaching an operator.

Date: March 30th, 2026

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): +1-203-518-9843

Conference ID: INMUNE

A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=96ca7c85d7

A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication, visit our website at www.inmunebio.com.

(Press release, INmune Bio, MAR 30, 2026, View Source [SID1234664051])

Zymeworks Receives U.S. FDA Fast Track Designation for ZW191, an FRα-Targeting Antibody-Drug Conjugate

On March 30, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).

ZW191 is an ADC engineered to target FRα, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers,2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

The FDA’s Fast Track designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.

"Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer. Notably, the designation was granted irrespective of FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection," said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer at Zymeworks. "This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers."

Zymeworks is currently evaluating ZW191 in a Phase 1 clinical study (NCT06555744) designed to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced solid tumors. The study is designed to further characterize ZW191’s clinical activity and safety to inform its future development strategy.

(Press release, Zymeworks, MAR 30, 2026, View Source [SID1234664050])

BeyondSpring Announces Plinabulin and ADC Combination Poster Presentation at AACR Annual Meeting 2026

On March 30, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported that the Company will have a poster presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), taking place on April 17 through 22, 2026 in San Diego, California.

Presentation Details:

Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-based Antibody-drug Conjugates Without or With Immune Checkpoint Inhibitor
Presenter / Authors: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang
Presentation Time: April 21, 2026, 2PM to 5PM PT
Location: Poster Section 8 at San Diego Convention Center
Session Category: Immunology
Session Title: T Cell Engagers 2 / Antibody-Drug Conjugates 1
Poster Board Number: 16
Poster Number: 5597

(Press release, BeyondSpring Pharmaceuticals, MAR 30, 2026, View Source [SID1234664049])

CERo Therapeutics Doses Second Patient in Cohort 2 of Phase 1 CER-1236 Trial

On March 30, 2026 CERo Therapeutics Holdings, Inc., (OTCQB: CERO) ("CERo" or the "Company") an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, reported it has dosed the second patient in the second cohort (fifth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies, including acute myeloid leukemia (AML), with planned expansion into myelodysplastic syndromes (MDS) and myelofibrosis (MF). With more than seven days of follow-up completed after the second patient’s infusion, protocol-defined monitoring of safety, pharmacokinetic, pharmacodynamic, and clinical activity endpoints is ongoing.

As previously presented at the February Tandem Meetings in Salt Lake City, investigators reported no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, no dose-limiting toxicities during the 28-day assessment window, and in vivo cell expansion with peak levels observed between days 10 and 14 following infusion. In the same presentation, the Company reported observations from a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level and experienced 72 consecutive days of platelet transfusion independence. These data informed the protocol amendment expanding enrollment into patients with MDS and MF.

Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "The study is progressing according to protocol, with ongoing evaluation of safety, pharmacokinetics, pharmacodynamics, and clinical activity. The data generated to date support continued dose escalation and planned expansion of enrollment into patients with advanced myelodysplastic syndrome (MDS) and myelofibrosis (MF). These are patient populations with substantial unmet need, and we are committed to continuing the clinical evaluation of CER-1236 as a potential new cell therapy approach for patients with these diseases."

The first-in-human, multi-center, open-label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for subsequent expansion, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose-limiting toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Based on emerging safety data and clinical observations, the trial has recently been amended to include transfusion-dependent myelodysplastic syndromes (TD-MDS), high-risk MDS (HR-MDS), or post-JAK-inhibitor myelofibrosis (MF).

CERo CEO Chris Ehrlich added, "CERo continues to execute the CERTAIN-T trial, with completion of the second cohort approaching. The study data continue to reinforce ongoing dose escalation and planned expansion into additional patient populations. We are grateful to the patients, investigators, study sites, and the CERo team for their contributions, and we look forward to sharing additional data as the study progresses."

(Press release, Cero Therapeutics, MAR 30, 2026, View Source [SID1234664048])