Azitra, Inc. Announces Poster Presentation at ASGCT 2026 Highlighting ATR-01 Program for Ichthyosis Vulgaris

On April 28, 2026 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the presentation of new preclinical data from its ATR-01 program at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT 2026").

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The poster highlights Azitra’s engineered live biotherapeutic candidate ATR01-616, which is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss (TEWL).

The data being presented at ASGCT (Free ASGCT Whitepaper) 2026 highlight ATR01-616’s mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain, with peak production observed 6–8 hours following application. In an ex vivo pig skin model, ATR01-616 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier.

"These data provide compelling validation of our ATR-01 program and its potential to address the underlying cause of ichthyosis vulgaris," said Francisco Salva, Chief Executive Officer of Azitra. "By using the skin’s natural bacteria to deliver functional filaggrin domains deeper into the epidermis, we are advancing a differentiated approach designed to restore skin barrier function and target the protein to where it is needed to address this genetically driven disease. The findings presented at ASGCT (Free ASGCT Whitepaper) build on our previously reported positive preclinical data for ATR-01 and further support the program’s advancement toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris."

ATR01-616 is a topical formulation containing a genetically engineered S. epidermidis strain designed as an auxotroph for controlled growth and optimized to secrete therapeutic filaggrin fragments. This approach enables localized, sustained delivery of protein therapeutics directly to affected skin, potentially overcoming limitations of existing treatments that do not address underlying disease biology and positioning ATR-01 as a novel, microbiome-based modality within dermatology.

Poster Details

Title: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris
Presenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc.
Abstract Number: 2691
Session: Gene Addition: Non-Viral Vectors
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting

(Press release, Azitra, APR 28, 2026, View Source [SID1234664850])

Novartis delivered strong growth in priority brands and launches in Q1; FY 2026 guidance reaffirmed

On April 28, 2026 Vas Narasimhan, CEO of Novartis reported on Q1 2026 results, said:

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"Novartis delivered a strong start to 2026 across our priority brands and launches, while US generic erosion weighed on results in Q1 as expected. We continued to advance our pipeline, with compelling Phase III results for remibrutinib in chronic inducible urticaria and Phase II data in food allergy, reinforcing the medicine’s pipeline-in-a-pill potential. We also completed the acquisition of Avidity and announced early-stage deals to support our breast cancer and allergic disease franchises. With the momentum we are seeing across the business, we remain on track to deliver our full year guidance and look forward to multiple readouts in the second half that could raise our mid- to long-term growth outlook."

Key figures

Q1 2026 Q1 2025 % change

USD m3 USD m3 USD cc
Net sales 13 113 13 233 -1 -5
Operating income 4 235 4 663 -9 -11
Net income 3 156 3 609 -13 -13
EPS (USD) 1.65 1.83 -10 -11
Free cash flow 3 330 3 391 -2

Core operating income 4 897 5 575 -12 -14
Core net income 3 794 4 482 -15 -17
Core EPS (USD) 1.99 2.28 -13 -15

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 32 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 6. 3. USD millions unless indicated otherwise.

Strategy
Our focus
Novartis is a "pure-play" innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.
Financials
First quarter
Net sales were USD 13.1 billion (-1%, -5% cc), with volume contributing 13 percentage points to growth, more than offset by 14 percentage points of generic competition. Pricing had a negative impact of 4 percentage points, including net 1 percentage point from revenue deduction adjustments in the US, and currency had a positive impact of 4 percentage points.

Operating income was USD 4.2 billion (-9%, -11% cc), declining due to lower net sales and higher R&D investments, partly offset by higher divestment gains.

Net income was USD 3.2 billion (-13%, -13% cc), mainly due to lower operating income. EPS was USD 1.65 (-10%, -11% cc), due to lower net income, partly offset by the benefit of the lower weighted average number of shares outstanding.

Core operating income was USD 4.9 billion (-12%, -14% cc), declining due to lower net sales and higher R&D investments. Core operating income margin was 37.3% of net sales, decreasing 4.8 percentage points (4.1 percentage points in cc).

Core net income was USD 3.8 billion (-15%, -17% cc), mainly due to lower core operating income. Core EPS was USD 1.99 (-13%, -15% cc), due to lower core net income, partly offset by the benefit of the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 3.3 billion, broadly in line with the prior-year quarter.

Q1 priority brands
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q1 growth) including:

Kisqali (USD 1 516 million, +55% cc) sales grew strongly across all regions, with continued momentum in the early breast cancer indication as well as leadership in metastatic breast cancer.
Pluvicto (USD 642 million, +70% cc) sales showed continued strong demand in the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) setting in the US, as well as access expansion ex-US.
Kesimpta (USD 1 164 million, +26% cc) sales grew across all regions, driven by increased demand and strong access.
Leqvio (USD 452 million, +69% cc) accelerated growth ex-US, driven by strong uptake in China following NRDL-listing.
Scemblix (USD 433 million, +79% cc) sales grew across all regions, with continued strong momentum from the early-line indication in the US, Japan and Germany.
Fabhalta (USD 169 million, +103% cc) sales more than doubled in Q1, reflecting continued expansion in PNH and renal indications.
Rhapsido (USD 37 million) continued to show strong early uptake in the US, supported by a free drug program to facilitate patient access and increasing coverage.
Cosentyx (USD 1 566 million, -2% cc) sales were broadly stable. US sales declined, as demand growth was offset by positive revenue deduction adjustments in the prior-year quarter. Ex-US, sales continued to grow. Underlying sales growth globally was +2% cc.
Zolgensma Group (USD 302 million, -12% cc) sales declined, reflecting a lower incidence of SMA, despite continued strong share in the incident population, as well as treatment phasing.
Net sales of the top 20 brands in the first quarter

Q1 2026 % change

USD m USD cc
Cosentyx
– excluding revenue deduction adjustments* 1 566 2
5 -2
2
Kisqali 1 516 59 55
Entresto 1 305 -42 -46
Kesimpta 1 164 29 26
Pluvicto 642 73 70
Jakavi 557 13 5
Tafinlar+Mekinist 493 -11 -14
Ilaris 475 13 10
Leqvio 452 76 69
Scemblix 433 82 79
Xolair 388 -15 -20
ZolgensmaGroup 302 -8 -12
SandostatinGroup 287 -9 -12
Lutathera 211 9 7
ExforgeGroup 203 13 7
Promacta/Revolade 184 -66 -68
Fabhalta 169 109 103
Tasigna 155 -59 -61
DiovanGroup 150 0 -4
Myfortic 111 12 9
Top 20 brands total 10 763 1 -3
*Q1 sales growth impacted by US revenue deduction adjustments in the current and prior year.

R&D update – key developments from the first quarter
New approvals
Cosentyx
(secukinumab) FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa (HS) in pediatric patients aged 12 years and older, making it the only IL‑17A inhibitor approved for this population.
Regulatory updates
Rhapsido
(remibrutinib) EMA’s CHMP adopted a positive opinion recommending marketing authorization for remibrutinib as an oral treatment for chronic spontaneous urticaria (CSU) in adults with an inadequate response to H1‑antihistamine therapy.
Ianalumab
(VAY736) FDA granted Breakthrough Therapy designation and priority review to ianalumab for the treatment of Sjögren’s disease, following the first global Phase III trials to demonstrate a statistically significant reduction in disease activity.

Regulatory submissions were completed for ianalumab in the US, Europe, China and Japan.
Cosentyx
(secukinumab) Regulatory submissions were completed for Cosentyx in polymyalgia rheumatica (PMR) in the US, Europe and Japan.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Novartis withdrew its EMA type II variation application for Pluvicto to treat adult patients with PSMA+ mCRPC pre-chemotherapy, following CHMP feedback that they would not support the application. The withdrawal is not related to the quality, efficacy or safety of Pluvicto and does not impact ongoing clinical trials, approved indications or pending regulatory submissions inside or outside the EU.

Importantly, the PSMAfore study, which supported the application, was the basis for the successful approval of Pluvicto in the pre-chemotherapy setting in the US, Japan and China. Pluvicto’s value in this population is also reflected in evidence-based recommendations from leading professional guidelines, including ESMO (Free ESMO Whitepaper), EAU, ASCO (Free ASCO Whitepaper) and NCCN Guidelines.
Results from ongoing trials and other highlights
Remibrutinib Positive topline results from the pivotal Phase III RemIND trial showed oral remibrutinib met its primary endpoint in chronic inducible urticaria (CIndU), achieving statistically significant and clinically meaningful complete response rates versus placebo at Week 12 across the three most prevalent CIndU types: symptomatic dermographism, cold urticaria and cholinergic urticaria. Remibrutinib was well tolerated and demonstrated a favorable safety profile, with no liver safety concerns reported. Based on these results, an sNDA for the treatment of symptomatic dermographism has been submitted to the FDA. Full data will be presented at an upcoming medical congress and submitted to health authorities globally.

In a Phase II study in adults with IgE‑mediated peanut allergy, remibrutinib demonstrated superior efficacy versus placebo, with dose‑dependent effects and a rapid onset of action, and was well tolerated. Data were presented at the AAAAI Annual Meeting. A Phase III program in food allergy is on track to start in H2 2026.
Fabhalta
(iptacopan) In the Phase III APPLAUSE‑IgAN study, final two‑year results published in The New England Journal of Medicine showed that Fabhalta slowed kidney function decline by 49.3% versus placebo and reduced the risk of composite kidney failure events in adult patients with IgA nephropathy (IgAN). The safety profile was consistent with previous findings. Fabhalta was granted priority review by FDA for traditional approval.
Vanrafia
(atrasentan) Final results from the Phase III ALIGN study showed a slowing in kidney function decline in IgAN patients treated with Vanrafia, with a positive difference in eGFR change from baseline vs. placebo at Week 136 (4 weeks after the end of study treatment, p = 0.057) and at Week 132 (at the end of treatment, nominal p = 0.039). Safety was consistent with previous findings. Novartis plans to submit these data for traditional approval in H1 2026.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Real‑world analyses from the Novartis PRECISION platform showed that Pluvicto achieved a median progression‑free survival (PFS) of 13.5 months in men with PSMA+ mCRPC who were taxane‑naïve and had received at least one androgen receptor pathway inhibitor (ARPI). Longer median PFS was observed when Pluvicto was initiated after one prior ARPI compared with use after multiple ARPIs. Data were presented at the ASCO (Free ASCO Whitepaper)-GU Symposium.
Cosentyx
(secukinumab) In a matched adjusted indirect comparison analysis of efficacy and safety from Phase III trials in HS, including SUNSHINE and SUNRISE, Cosentyx showed greater flare prevention and a lower risk of Candida infections compared with bimekizumab through Week 48, while maintaining similar HiSCR50 responses. Data were presented at AAD.
Del-zota One‑year data from the Phase I/II EXPLORE44 and EXPLORE44‑OLE studies evaluating del-zota in individuals with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44) showed sustained reductions in serum creatine kinase levels, significant increases in dystrophin, and improvements in multiple functional measures. Safety profile observed to date is consistent with earlier findings. Data were presented at MDA.
Del-desiran Final results from the Phase I/II MARINA study of del-desiran in adults with myotonic dystrophy type 1 (DM1), published in The New England Journal of Medicine, showed effective delivery to muscle and a reduction in DMPK mRNA, and improvements across multiple functional measures. Safety profile observed to date is consistent with earlier findings. Del‑desiran is currently being evaluated in the Phase III HARBOR study in DM1, with readout anticipated in H2 2026.
Selected transactions Novartis successfully completed the acquisition of Avidity Biosciences, strengthening its late-stage neuroscience pipeline and advancing its xRNA strategy.

Novartis entered into an agreement with Synnovation Therapeutics to acquire SNV4818, a pan‑mutant selective PI3Kα inhibitor currently in Phase I/II for patients with HR+/HER2‑ breast cancer and other advanced solid tumors. The program aligns with Novartis’ strategy in breast cancer, and fits naturally alongside CDK inhibitors as well as endocrine (hormonal) therapies as part of a potential combination regimen. The transaction is expected to close in H1 2026, subject to customary closing conditions.

Novartis entered into an agreement to acquire Excellergy, including Exl-111, a half-life extended, high-affinity anti-IgE antibody in Phase I, with a differentiated mechanism designed to dissociate receptor-bound IgE and drive faster and deeper FcεRIα downregulation. This acquisition builds on deep Novartis expertise in IgE biology and allergic disease, with the potential to offer earlier symptom relief, stronger disease control and more convenient dosing. The transaction is expected to close in H2 2026, subject to customary closing conditions.
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

In Q1 2026, Novartis repurchased a total of 10.4 million shares for USD 1.6 billion on the SIX Swiss Exchange second trading line under the up-to USD 10 billion share buyback announced in July 2025 (with up to USD 6.1 billion still to be executed). In addition, 2.0 million shares (equity value of USD 0.3 billion) were repurchased from employees. In the same period, 12.3 million shares (equity value of USD 0.3 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the 2026 dilution related to equity-based compensation plans of employees over the remainder of the year, in addition to the share repurchases under the up-to USD 10 billion share buyback. Consequently, the total number of shares outstanding decreased by 0.1 million versus December 31, 2025. These treasury share transactions resulted in an equity decrease of USD 1.6 billion and a cash outflow of USD 1.9 billion.

Net debt increased to USD 38.1 billion at March 31, 2026, compared to USD 21.9 billion at December 31, 2025. The increase was mainly due to the free cash flow of USD 3.3 billion being more than offset by the net cash outflow for M&A and intangible asset transactions of USD 12.5 billion, the USD 6.2 billion annual net dividend payment in March (which is the gross dividend of USD 9.1 billion reduced by the USD 2.9 billion Swiss withholding tax paid in April 2026, according to its due date), and cash outflows for treasury share transactions of USD 1.9 billion.

As of Q1 2026, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2026 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow low single-digit
Core operating income Expected to decline low single-digit

Foreign exchange impact
If late-April exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 2 percentage points on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1

Q1 2026 Q1 2025 % change
USD m2 USD m2 USD cc
Net sales 13 113 13 233 -1 -5
Operating income 4 235 4 663 -9 -11
As a % of sales 32.3 35.2
Net income 3 156 3 609 -13 -13
EPS (USD) 1.65 1.83 -10 -11
Net cash flows from operating activities 3 676 3 645 1
Non-IFRS measures
Free cash flow 3 330 3 391 -2
Core operating income 4 897 5 575 -12 -14
As a % of sales 37.3 42.1
Core net income 3 794 4 482 -15 -17
Core EPS (USD) 1.99 2.28 -13 -15

(Press release, Novartis, APR 28, 2026, View Source [SID1234664811])

BioCryst to Present at Upcoming Investor Conferences

On April 28, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences:

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Bank of America Health Care Conference in Las Vegas on Tuesday, May 12, 2026, at 4:40 p.m. ET.
Jefferies Global Healthcare Conference in New York on Wednesday, June 3, 2026, at 3:45 p.m. ET.

Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, APR 28, 2026, View Source [SID1234664851])

Fosun Pharma Announces Q1 2026 Results: Net Profit Attributable to Shareholders After Deducting Non-Recurring Gains and Losses Increased by 21.96% YoY, With Strong Pipeline Execution

On 28 April, Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) reported its results for the first quarter of 2026 (the reporting period). During the reporting period, the Company achieved a total revenue of RMB 10,073 million, representing a year-on-year increase of 6.93%. Regarding R&D investment, the Company firmly implemented its innovation transformation strategy. During the reporting period, the R&D expenditure increased to RMB 897 million, increased by 1.59% YoY. While increasing the R&D intensity, the Company maintained a positive growth trend in profit. Net profit attributable to shareholders of the list company after deducting extraordinary gain or loss was RMB 501 million, up 21.96% year-on-year. Net profit attributable to shareholders of the listed company was RMB 871 million, increased by 13.87% YoY. Net cash flows generated from operating activities was RMB 1,149 million, up 8.8% YoY.

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In the first quarter of 2026, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma firmly continued to advance its innovation transformation, promoted the deep synergy between innovation and R&D and global operations, and further enhanced the foundation for high-quality development. Driven by the continuous increase in R&D investment, the Company’s transformation of innovative achievements continues to materialize. During the reporting period, the NDA for 4 Innovative Drugs were accepted by the NMPA or the U.S. FDA, and 14 clinical trials for Innovative Drugs (calculated by approval) were approved by domestic and overseas regulatory authorities, covering core therapeutic areas such as oncology. In the Pharma R&D Annual Review 2026 white paper released by the world-known consulting firm Citeline, Fosun Pharma ranked among the global top 20, gained international professional recognition for its innovative R&D strength and pipeline quality.

Deepening Core Technology Platforms to Consolidate Advantages in Oncology and Other Fields

Fosun Pharma has established an open-ended R&D system that combines in-house R&D, co-development, licensing, fund incubation, and industrial investment, also focused on strengthening core technology platforms such as antibodies/ADC, small molecules, and cell therapy, continuously consolidating its innovation moat in core therapeutic areas including oncology.

In the field of antibody/ADC technology platform, Shanghai Henlius, a subsidiary of Fosun Pharma, has steadily advanced the approvals and clinical progress of several self-developed biological drugs. Notably, denosumab injection (HLX14) secured approval in Canada in March 2026, covering all indications of the reference product approved locally, achieving a global commercialization breakthrough in areas such as osteoporosis, bone metastasis from tumors, and giant cell tumor of bone. The NDA for bevacizumab injection (HLX04) was accepted in the U.S., marking a new milestone in the Company’s international registration capabilities for biosimilars. HLX43, an antibody-drug conjugate targeting PD-L1, is expected to create synergy with HLX07 or serplulimab injection for the treatment of advanced colorectal cancer and other solid tumors. HLX3901, a tetraspecific antibody of DLL3×DLL3×CD3×CD28, received approval for clinical trial, demonstrating significant potential in refractory solid tumors through multi-target synergistic activation of immune cells.

In the field of small molecule innovative drug platform, in January 2026, the NDA for foritinib succinate capsules (SAF-189), Fosun Pharma’s Class 1 innovative drug, was accepted by the NMPA, intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), expected to provide a new option for precision treatment of lung cancer. In February 2026, the NDA for the self-developed MEK 1/2 inhibitor luvometinib tablets (Trade name in Chinese mainland: Fu Mai Ning) for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) have been accepted and granted in the priority review by the NMPA. This marks a critical step toward full-age coverage following its approval for pediatric and adolescent NF1 patients in May 2025, also brings new hope to a large number of adult NF1 patients in China who lack effective drug treatments. Additionally, the NDA for methoxyetomidate hydrochloride injection (ET-26), a Class 1 innovative drug self-developed by the subsidiary Avanc Pharma for anesthesia induction and short-term surgical anesthesia, was also accepted.

In the field of prospective layout of early-stage pipeline, several new molecules have been approved for the clinical trials: FXB0871, a PD-1-targeted IL-2 fusion protein, was approved for clinical trials in locally advanced or metastatic solid tumors. Based on the ATTENUKINE platform, FXB0871 is expected to achieve high efficacy and low toxicity. FXS0683, a next-generation Bcl-2 inhibitor, was approved for Phase I clinical trials in hematological malignancies. Innovative molecule including HLX97 (a KAT6A/B small molecule inhibitor) and HLX3901 (tetra specific antibody of DLL3×DLL3×CD3×CD28) were approved for clinical trials, widely covering refractory solid tumors such as breast cancer and small cell lung cancer. Meanwhile, HLX22 (anti-HER2 monoclonal antibody) entered phase II clinical trials for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in combination with HLX87. HLX43 (PD-L1 ADC) in combination with HLX07 or serplulimab injection, and HLX701 (CD47 fusion protein), among others, have entered Phase I clinical trials, further enhancing the Company’s layout in the fields of tumor immunology and targeted therapy.

Expanding Global Commercialization Network and Enhancing Academic Influence

During the reporting period, Fosun Pharma’s global registration and commercialization network continued to expand. The overseas registration of products like denosumab and bevacizumab progressed steadily. The Company reached deep collaborations with global partners such as Eisai and Abbott to accelerate the market coverage of innovative products in Japan, Asia-Pacific, Middle East, Africa, and Eastern Europe.

In the academic field, several innovation achievements were presented at top international conferences such as AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper). The Phase III study data of luvometinib tablets for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) was selected for a rapid oral abstract session at 2026 ASCO (Free ASCO Whitepaper), the study results will be released for the first time during the meeting. At the 2026 AACR (Free AACR Whitepaper) Annual Meeting, Shanghai Henlius, a Fosun Pharma’s subsidiary, presented preclinical data for the novel trispecific T-cell engager HLX3902 and the tetraspecific antibody HLX3901, demonstrating best-in-class treatment potential, building a solid foundation for the future clinical development.

AI Embracement: Driving Digital Transformation via FoSTRAID

Fosun Pharma continues to deepen its digitalization and AI strategic layout, and systematically advances the platformisation, engineering and scaled implementation of AI capabilities focusing on core aspects such as new drug R&D, clinical research, products and services, and operation management. On this basis, the fully AI- embracing strategy centered on FoSTRAID (Fosun Pharma Strategic Transformation via AI & Data science) was further defined and steadily advanced. By integrating resources, a digital-intelligence architecture that promotes synergistic development across "foundation — platform — data — agent — scenario — mechanism" has been established.

The self-developed PharmAID Pharmaceutical Intelligence Platform deeply applies large language models, fine-tuned with professional medical corpora and R&D data. It integrates full-cycle of decision-making tools including competitor analysis, clinical competitive performance evaluation, NDA approval prediction, and peak sales estimation, comprehensively applied in key scenarios such as target discovery, molecular optimization, clinical writing, intelligence retrieval, and literature interpretation, providing systematic and data-driven support for drug R&D decision-making.

Looking ahead, Fosun Pharma will continue to adhere to the dual drivers of innovation and globalization, deepen its core technology platforms, promote the implementation of AI strategy and accelerate the transformation of its pipeline and global market access. The Company remains committed to providing high-quality healthcare products and services to patients worldwide, striving to become a leading global healthcare innovation integrator.

(Press release, Fosun Pharma, APR 28, 2026, View Source [SID1234664870])

BioLineRx and Hemispherian Announce First Patient Dosed in Phase 1/2a Study of GLIX1 for the Treatment of Glioblastoma (GBM)

On April 28, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported that the first patient has been dosed in the first-in-human, Phase 1/2a study of GLIX1 for the treatment of recurrent and progressive glioblastoma (GBM) and other high-grade gliomas. The GLIX1 program is being conducted under a collaboration between BioLineRx and Hemispherian announced in September 2025.

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The patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center. Northwestern University, led by lead investigators Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffit Cancer Center, led by Dr. Patrick Grogan, will also be participating in the study.

GLIX1 is an oral, first-in-class, small molecule with a novel mechanism of action, designed to activate TET2 and drive tumor DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors. Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. GBM remains one of the most aggressive and treatment-resistant cancers, and there is an urgent need for breakthrough innovation and more effective treatment options.

In multiple pre-clinical models, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity, excellent blood-brain-barrier penetration, and a favorable safety profile.

"The dosing of the first patient in our Phase 1/2a study of GLIX1 is an important milestone for BioLineRx and, more importantly, for patients battling glioblastoma, a very challenging tumor where there has been very little innovation over the past 20 years," said Philip Serlin, Chief Executive Officer of BioLineRx. "We believe GLIX1 has the potential to offer a novel therapeutic approach in this cancer indication, as well as in multiple other cancer indications, where DNA damage repair is critical for cancer survival. We are excited to advance GLIX1 development into this first-in-human clinical trial and look forward to initial data in the first half of 2027."

Zeno Albisser, Chief Executive Officer of Hemispherian, added, "The initiation of patient dosing in this important study represents a watershed event for Hemispherian and GLIX1. This is the culmination of years of focused scientific and operational work, and an important step toward bringing a new therapeutic approach to patients with glioblastoma. We are encouraged by our preclinical data and look forward to generating initial clinical insights as the trial progresses."

Phase 1/2a clinical trial design (NCT07464925)

The Phase 1 part of the trial is a dose escalation part where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers with/without standard of care (e.g., in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

(Press release, BioLineRx, APR 28, 2026, View Source [SID1234664852])