On August 26, 2026 Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, reported the submission of its supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") for REVTORPYK (gedatolisib) for the treatment of patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") with a PIK3CAmutation, following progression on or after treatment with at least one line of endocrine therapy.

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"This submission allows us to potentially make REVTORPYK available to all patients with HR+/HER2- locally advanced or metastatic breast cancer, regardless of PIK3CAmutation status," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "In the PIK3CA mutant cohort of the VIKTORIA-1 trial, REVTORPYK demonstrated compelling safety and efficacy results. Pending regulatory approval, we believe REVTORPYK has the potential to become an important treatment option in this indication."

The application to the FDA is supported by positive results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In the trial, REVTORPYK plus fulvestrant and palbociclib (the "REVTORPYK-triplet") reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median progression-free survival ("PFS") was 11.1 months with the REVTORPYK-triplet versus 5.6 months with alpelisib plus fulvestrant. REVTORPYK plus fulvestrant (the "REVTORPYK-doublet") reduced the risk of disease progression or death by 49% versus alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013). Median PFS was 11.3 months with the REVTORPYK-doublet versus 5.6 months with alpelisib plus fulvestrant. The REVTORPYK regimens demonstrated robust and durable responses: 49% objective response rate ("ORR") and median duration of response ("DOR") of 15.7 months for the REVTORPYK-triplet and 36% ORR and median DOR of 24.2 months for the REVTORPYK-doublet. The safety data for both regimens were generally consistent with previously reported data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial.

REVTORPYK in combination with fulvestrant, with or without palbociclib, was approved by the FDA on July 14, 2026, for the treatment of patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

"The recent FDA approval of REVTORPYK marked an important milestone for Celcuity and for patients with PIK3CA wild-type HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "We are deeply committed to expanding the availability of REVTORPYK to a broader population of patients. We look forward to working collaboratively with the FDA on this application to potentially bring this treatment to patients with PIK3CAmutated locally advanced or metastatic breast cancer."

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.3

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The trial enrolled 701 subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA wild-type cohort of VIKTORIA-1 have been previously reported. For the PIK3CA mutant cohort, 350 subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib-triplet, alpelisib and fulvestrant, or the gedatolisib-doublet.

About REVTORPYK (gedatolisib)

REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.4,5,6

REVTORPYK is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration resistant prostate cancer.

Indication Statement

REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS

REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

USE IN SPECIFIC POPULATION

Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products.

Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility.

Please see full Prescribing Information, including Patient Information, for REVTORPYK.

You may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

(Press release, Celcuity, AUG 26, 2026, View Source [SID1234670346])

On August 26, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company whose principal value driver is a financial interest in the HER2-targeting antibody programme HLX22, reported its interim results for the second quarter of 2026 and provided a business update.

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"During the second quarter we assessed how best to create value from our portfolio. After the quarter, we decided to discontinue independent development of mitazalimab and to refocus Alligator on its financial interest in HLX22, which offers potential future revenue without development costs. We will seek to out-license or divest mitazalimab in the near term, and we are reducing the organisation to the minimum staffing required to oversee the HLX22 programme."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Alternatives for Phase 3 development: Alligator stated that it was exploring alternative routes to Phase 3 development of mitazalimab in first-line metastatic pancreatic cancer and had signed a letter of intent with the French non-profit cancer research organisation Unicancer to assess the feasibility of a global investigator-sponsored Phase 3 study. No development decisions had been taken.
New data at AACR (Free AACR Whitepaper) 2026: Data from a Phase 1 investigator-initiated study (NCT06205849) of intratumoral mitazalimab given in conjunction with irreversible electroporation in locally advanced pancreatic cancer were presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. All six patients with completed pre- and post-treatment analyses showed T-cell reactivity to patient-specific neoantigens, and reactivity increased following treatment.
HLX22

HLX49 – preclinical data at AACR (Free AACR Whitepaper) 2026: Henlius presented preclinical data for HLX49, a HER2 biparatopic antibody-drug conjugate that incorporates HER2 binding domains from HLX22. Alligator’s financial interest extends to products derived from HLX22.
Long-term follow-up: Henlius reported that follow-up of more than 39 months indicates that patients treated with HLX22 continue to demonstrate extended progression-free survival. The update did not include new numerical efficacy data.
Patients dosed in all regions of the global Phase 3 study: Henlius reported that the first patients were dosed in all regions participating in the global Phase 3 study of HLX22, comprising China, Japan, Korea, Latin America, Australia, the United States and Europe.
Company / Financial position

Annual General Meeting: The Annual General Meeting on 6 May 2026 elected four Board members. Anna Törner and Jörg Möller were elected as new members and Hans-Peter Ostler was re-elected Chairman. The Meeting also authorised the Board to resolve on the issue of ordinary shares, convertibles and warrants corresponding to no more than 20 percent of the number of outstanding ordinary shares.
SIGNIFICANT EVENTS AFTER THE QUARTER

Discontinued independent development of mitazalimab and strategic refocus: On 23 July 2026 Alligator announced that it will discontinue all further independent development of mitazalimab, including preparations for and support of Phase 3 studies, and refocus on preserving the future royalty potential of its financial interest in the out-licensed HLX22 programme. Alligator will wind down remaining operations and reduce the organisation to the minimum staffing required to oversee the HLX22 programme, subject to negotiations with the trade unions concerned. Alligator intends to continue to supply mitazalimab to ongoing externally funded investigator-initiated studies, including the randomised Phase 2/3 study in biliary tract cancer, subject to available funding. Alligator also intends to seek to out-license or divest mitazalimab as a broader immuno-oncology asset in the near term.
Rights issue of units and bridge loans: Alligator announced a rights issue of units of approximately SEK 125.6 million before issue costs, conditional upon approval by the Extraordinary General Meeting on 26 August 2026. The rights issue is covered by subscription undertakings and guarantee commitments of up to SEK 58.8 million, corresponding to approximately 47 percent. Alligator also raised bridge loans of SEK 19 million and renegotiated its outstanding loan from Fenja Capital, whereby the maturity was changed from 30 September 2026 to 30 June 2027.
FINANCIAL SUMMARY FOR Q2 2026
The financial summaries for the periods ending 30 June 2026 and 30 June 2025 are presented below.

All amounts in MSEK, unless specified April – June 2026 April – June 2025 January – June 2026 January – June 2025
Net sales - - - -
Operating profit/loss -36.2 -22.3 -54.0 -66.0
Profit/loss for the period -37.8 -1.7 -36.4 -10.0
Cash flow for the period -16.4 5.1 -45.5 -29.6
Cash and cash equivalents 16.6 33.9 16.6 33.9
Earnings per share before and after dilution*, SEK -0.06 -0.08 -0.06 -0.69
* Adjusted for reverse share split in 2025.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Wednesday, 26 August 2026, at 3 p.m. CEST / 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session.

The call will be held in English. Attendees need to register by following this link.

(Press release, Alligator Bioscience, AUG 26, 2026, View Source [SID1234670345])

On August 25, 2026 Genrix Biopharmaceutical reported China’s National Medical Products Administration (NMPA) has granted conditional approval to velinotamig (GR1803), a BCMA×CD3 bispecific antibody developed by the company and partnered with Fosun Pharma’s YaoPharma, for adults with heavily pretreated relapsed or refractory multiple myeloma (R/R MM).

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The approval covers adult patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

Velinotamig will be marketed in China under the brand name 维可妥 (Weiketu). The NMPA granted the product conditional approval as a Class 1 therapeutic biologic under approval number S20260066. (vip.stock.finance.sina.com.cn)

The approval represents an important milestone for Chongqing-based Genrix Bio and adds another BCMA-directed T-cell engager to China’s rapidly evolving multiple myeloma treatment landscape.

Velinotamig is a bispecific T-cell-engaging antibody designed to simultaneously bind B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells.

By bringing cytotoxic T cells into close proximity with BCMA-expressing tumor cells, the antibody is designed to activate T-cell-mediated killing of malignant plasma cells.

What differentiates velinotamig is its asymmetric affinity design.

According to YaoPharma, velinotamig’s binding affinity for BCMA is approximately two orders of magnitude — roughly 100-fold — higher than its affinity for CD3.

The rationale is to favor tumor-specific binding before strong T-cell engagement. By reducing CD3 affinity relative to BCMA affinity, the molecule is designed to limit nonspecific T-cell activation while retaining potent antitumor activity, potentially reducing toxicity associated with excessive immune activation. (en.yaopharma.com)

Phase I Data Show 89.5% Overall Response Rate
Clinical data presented from the Phase I program have shown deep responses in patients with heavily pretreated R/R multiple myeloma.

In the dose-expansion portion of the study, 60 patients were enrolled across three dose cohorts, including two cohorts receiving the recommended Phase II dose (RP2D) of 180 μg/kg, with or without a priming dose.

Among 57 efficacy-evaluable patients across dose levels, the overall response rate (ORR) was 89.5% (51/57). (researchgate.net)

At the 180 μg/kg RP2D, 48 patients were treated and achieved:

ORR: 87.5% (42/48)
≥VGPR: 70.8% (34/48)
≥CR: 37.5% (18/48)
MRD negativity: 54.2% (26/48)
Responses also appeared durable. At the July 1, 2025 data cutoff, median duration of response had not yet been reached, while the estimated probability of responders remaining in response at nine months was 78.8%.

The median follow-up among responders was 12.4 months, with many responses deepening as treatment continued. (researchgate.net)

Activity in Extramedullary Multiple Myeloma
One particularly noteworthy feature of the dataset was the substantial representation of patients with extramedullary multiple myeloma (EMM), a high-risk manifestation in which malignant plasma cells grow outside the bone marrow and which can be particularly difficult to treat.

Half of the 48 patients treated at 180 μg/kg had EMM at baseline.

Among these 24 patients, velinotamig produced an ORR of 83.3%, including four complete or stringent complete responses, nine very good partial responses and seven partial responses. (researchgate.net)

The median time to response was 2.1 months in the overall study population but only 0.75 months among patients without EMM.

These results suggest substantial antimyeloma activity even in a population containing a high proportion of patients with aggressive extramedullary disease.

Safety Profile
As with other T-cell-engaging bispecific antibodies, cytokine release syndrome (CRS) and hematologic toxicities were observed.

At the 180 μg/kg dose, cytokine release syndrome occurred in 89.6% of patients, but Grade 3 or higher CRS was reported in 6.3%.

Other frequently reported treatment-emergent adverse events included neutrophil-count decreases, white-blood-cell-count decreases, thrombocytopenia, anemia and infections including pneumonia. (researchgate.net)

The molecule’s approximately 100-fold BCMA-to-CD3 affinity differential was specifically engineered with the goal of reducing nonspecific T-cell activation and associated toxicity while maintaining effective recruitment of T cells against BCMA-positive myeloma cells. (en.yaopharma.com)

Fosun Pharma Secures Greater China Rights in RMB 1.82 Billion Deal
Velinotamig has also attracted significant commercial interest.

In May 2026, Genrix Bio entered into an exclusive licensing agreement with YaoPharma, a subsidiary of Fosun Pharma, covering Greater China.

Under the agreement, YaoPharma obtained exclusive rights to the clinical development and commercialization of velinotamig in mainland China, Hong Kong, Macau and Taiwan, along with specified manufacturing and process-development rights. (en.yaopharma.com)

The deal carries potential payments of up to RMB 1.82 billion, consisting of:

RMB 300 million upfront
Up to RMB 300 million in regulatory approval and technology-transfer milestones
Up to RMB 1.22 billion in sales milestones
Genrix is additionally eligible for tiered royalties ranging from the high-single digits to low-double digits on net sales in the licensed territory. (fangdalaw.com)

The NMPA approval therefore represents an important near-term milestone for the partnership only three months after the Greater China licensing agreement was signed.

On August 25, 2026 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its unaudited interim results for the first half of 2026 ("Reporting Period").

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Financial Highlights
Revenue: Revenue increased 18.4% YoY to RMB 11.8 billion (23.4% growth YoY on USD basis), reflecting broad-based growth across project stages and geographies, driven by strong demand for new IND-enabling programs, continued progression of projects through late-stage development and commercial manufacturing.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 28.1% YoY to RMB 5.4 billion, with gross margin of 46.2%. Adjusted gross profit increased 25.6% YoY to RMB 5.7 billion, with adjusted gross margin of 48.4%. Margin expansion, despite foreign exchange headwinds, was primarily driven by continued operating leverage, improved capacity utilization, and ongoing productivity gains through WuXi Biologics Business System (WBS) and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 3.5% YoY to RMB 4.4 billion with EBITDA margin of 37.1%, while adjusted EBITDA increased 24.9% YoY to RMB 5.4 billion, with adjusted EBITDA margin expanding to 45.6%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 5.8% YoY to RMB 2.9 billion, while net profit attributable to owners of the company grew 4.3% YoY to RMB 2.4 billion.

Adjusted Net Profit and Adjusted Net Profit Attributable to Owners of the Company: Adjusted net profit increased 38.6% YoY to RMB 3.9 billion, while adjusted net profit attributable to owners of the Company rose 38.4% YoY to RMB 3.3 billion. The difference between IFRS and adjusted net profit growth was primarily driven by the unrealized foreign exchange loss due to USD devaluation in the reporting period, and the investment gains in the prior year baseline, both of which were excluded from the adjusted profit measurement.

Basic Earnings Per Share (EPS): Basic EPS rose 3.4% to RMB 0.60 (June 30, 2025: RMB 0.58), while diluted EPS advanced 5.5% to RMB 0.58 (June 30, 2025: RMB 0.55).

Adjusted Earnings Per Share (Adjusted EPS): Adjusted basic EPS increased 37.3% to RMB 0.81 (June 30, 2025: RMB 0.59), while adjusted diluted EPS increased 39.3% to RMB 0.78 (June 30, 2025: RMB 0.56).

Business Highlights
Integrated Project Adds

The Group added 169 new integrated projects in H1 2026, including 123 organically added projects (+43% YoY); WuXi XDC’s BioDlink acquisition brought 46 new integrated projects, bringing the Group’s total to 1,064. 2/3 of the 123 organic additions originated in the U.S. and EU, reflecting continued strong demand from both big pharma and biotech. Now with 78 projects in Phase III and 28 in commercial manufacturing stage, the pipeline continues to provide strong visibility into the future manufacturing revenue growth.

Of the 123 new organic projects, 16 were post-IND wins under the Group’s "Win-the-Molecule" (WtM) strategy, including 4 Phase III and 1 commercial project, bringing cumulative WtM projects to 128 since 2018. 70%+ of WtMs in H1 2026 were complex biologics modalities, while 2 were biosimilars.

Research

Research Services continued to make solid progress in H1 2026. As of June 30, 2026, Research Services supported 50+ active programs eligible for milestone payments and sales royalties, providing a growing base of potential high-margin, long-term revenue streams. 50%+ of these programs were sponsored by overseas clients, reflecting the continued globalization of the Group’s Research Services business.

Development

The Group supported 68 IND filings in H1 2026 and expects to expand annual filing capacity to 300 INDs by 2027. The filing capacity expansion will be supported by continued investment in development talents and higher per-capita productivity, in response to the strong growth globally.

Bi-/multi-specific antibodies and ADCs accounted for 70%+ of new projects, with their respective pipelines expanding to 221 and 328 projects. These complex biologics modalities continued to drive business growth, contributing 50%+ of Group revenue in H1 2026, up ~30% YoY.

WuXiaTM TrueSite, the Group’s targeted-integration CHO cell line platform introduced in October 2025 has been adopted in 70+ projects since its launch. The platform enables 6-month DNA-to-IND timelines and achieves average titers of 8+ g/L (up to 12 g/L) for mAbs and 7.5+ g/L (up to 10 g/L) for bi-/multi-specifics, improving productivity, reducing manufacturing scale requirements and lowering COGS. WuXiaTM TrueSite is expected to become an increasingly important differentiator for the Group’s Win-the-Molecule strategy. Its combination of faster development and higher cell-line productivity is particularly attractive for biosimilar programs, where speed and COGS are important success factors.

Manufacturing

As of June 30, 2026, the Group supported 78 Phase III projects and 28 commercial manufacturing projects. 5 late-stage and commercial projects originated from the Group’s "Win-the-Molecule" strategy, including 2 biosimilar projects. The Group has scheduled 34 PPQs in 2026 and another 30 in 2027 and has maintained a 100% PPQ campaign success rate to date.

The Group continued to advance its "Global Dual Sourcing" strategy to support growing commercial demands and strengthen global supply chain resilience, while accelerating manufacturing capacity expansion globally through continued investments and strategic asset acquisitions:

Shanghai Fengxian, China: MFG17 completed its first GMP campaign with zero deviations. With a current capacity of 9,000L, expandable to 20,000L, the facility supports both clinical and commercial manufacturing. DP15 achieved GMP release in April 2026.
Chengdu, China: The commercial microbial DS/DP facility achieved structural completion and key equipment delivery. Equipped with a 15,000L fermenter and capacity for up to 110 DS batches annually, the facility is expected to achieve GMP release by the end of 2026.
Hangzhou, China: The Group recently announced the proposed acquisition of Transcenta’s process development & manufacturing site in Hangzhou, China, which is adjacent to its existing Hangzhou operations. The facility is expected to create operational synergies and enable flexible capacity expansion in response to the growing client demands.
U.S.: Construction of MFG11 in Worcester, Massachusetts, with 36,000L (6 x 6,000L) of commercial manufacturing capacity, is progressing as planned. MFG18, in Cranbury, New Jersey, is being upgraded from a clinical manufacturing facility to have commercial manufacturing capabilities with 13,000L+ of total capacity, and has initiated its first PPQ campaign in the 1H of 2026.
Singapore: The DP facility reached topping out and is expected to provide approximately 100 million units of annual pre-filled syringe and vial capacity upon commencement of operations in 2027. The ongoing design of the 120,000L modular DS facility targets GMP readiness in 2029.
Ireland: Year-to-date, the Ireland site has secured three new large-scale manufacturing projects, and has commenced tech-transfer.

Business Portfolio Optimization
In July, 2026, the Group entered into an agreement to sell its 51.1% equity interest in BestChrom, a non-wholly owned subsidiary principally engaged in biologics purification media and chromatography columns, to an independent third party for an undisclosed amount. The transaction is expected to close in December 2026, subject to customary closing conditions, after which BestChrom will cease to be a consolidated subsidiary of the Group.

Backlog
As of June 30, 2026, total backlog reached US$ 25.1 billion, including US$ 12.6 billion service backlog and US$ 12.4 billion potential milestone payments. Backlog within 3 years reached US$ 5.5 billion, up~30% YoY, providing strong revenue visibility over the near term.

Quality
Since 2017, the Group has completed 49 regulatory inspections by global health authorities, including 23 by the U.S. FDA and EU EMA, with no critical findings or data integrity observations. As of June 30, 2026, the Group had obtained 166 facility license approvals across its global network and operated 15 GMP-certified manufacturing facilities, demonstrating its established global regulatory and quality capabilities.

Talent
As of June 30, 2026, the Group employed 14,705 people, including 5,180 scientists, with a key talent retention rate of 98.7%. To support continued business growth, the Group plans to further expand its workforce in H2 2026.

WBS (WuXi Biologics Business System) and Digitalization
WBS continued to drive operational excellence and productivity improvements across the organization. During the Reporting Period, the Group completed 55 Kaizen projects, contributing approximately 150 bps to gross margin improvement through enhanced productivity, cost optimization and process standardization.

The Group also continued to advance its digital manufacturing capabilities, with PatroLab enhancing process development, manufacturing efficiency and operational excellence through integrated data and advanced analytics.

Sustainability
Sustainability remains integral to the Group’s long-term strategy. During the Reporting Period, the Group continued to be recognized by leading global ESG rating agencies for its sustainability performance.

Management Comment
Dr. Chris Chen, CEO of WuXi Biologics, stated, "In H1 2026, WuXi Biologics delivered strong profitable growth, with revenue increasing 23.4% YoY in USD and adjusted gross margin expanding 280 bps to 48.4%, despite foreign exchange headwinds. Broad-based demand, continued operating leverage and productivity gains supported this performance. We added a record-high 123 organic integrated projects, up 43% YoY, while complex biologics accounted for 70%+ of new projects, further upgrading our pipeline mix.

Our technology differentiation is also translating increasingly into commercial competitiveness. WuXia TrueSite has been adopted in 70+ projects since launch, supporting faster development and higher cell-line productivity. We expect WuXia TrueSite to strengthen both our Follow-the-Molecule and Win-the-Molecule competitiveness, while its speed and potential cost advantages are particularly attractive for biosimilar programs. We’re well-positioned to capture incremental demand from digital advances in drug discovery and next-gen therapeutic platforms.

Visibility into future manufacturing growth continues to strengthen, supported by four distinct pillars: progression of our Follow-the-Molecule pipeline toward additional commercial approvals; continued Win-the-Molecule conversion; emerging biosimilar opportunities; and higher value capture through our integrated One DP platform. Looking ahead, we will continue to expand capacity and optimize our business portfolio in a demand-driven and disciplined manner, while investing in differentiated technologies and our global network to support sustained growth and long-term value creation for clients and shareholders."

Dr. Ge Li, Chairman of WuXi Biologics, stated, "H1 2026 reinforced the strength of WuXi Biologics’ integrated CRDMO platform and the long-term value of our continued investments in technology, quality and global capabilities. As biologics innovations continue to advance toward increasingly complex modalities, we remain committed to enabling our global partners through differentiated technologies, proven quality and reliable execution. Guided by our vision that ‘every biologic can be made,’ we will continue to invest for the long term, expand the capabilities of our global platforms and create long-term value for clients, shareholders and patients worldwide."

(Press release, WuXi Biologics, AUG 25, 2026, View Source [SID1234670672])

On August 25, 2026 Moleculin presented its corporate presentation.

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(Presentation, Moleculin, AUG 25, 2026, View Source [SID1234670445])