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The Building Safety Regulator has recently acted through the Health and Safety Executive to prevent the occupation of student accommodation in Newcastle-under-Lyme by obtaining an injunction, after concluding that Building Regulations compliance had not been achieved.

This type of enforcement action has significant implications for contractors, consultants, and their insurers, impacting both ongoing claims and remedial works, as well as future claims. If building owners are unable to sell or lease their developments, claim values may increase substantially due to increased or new claims for loss of profit or rent, loss of opportunity, LADs, and/or extended programme periods.

Key takeaway: If you or one of your Insureds act as a Dutyholder for a development or are undertaking remedial works commencing after 6 April 2024, there is an increased risk that, should the Building Safety Regulator deem those works non-compliant, the sale or occupation of the development may be prohibited, potentially resulting in significant increases in claimed losses and values.

Overview of Dutyholder Regime

The Building Safety Act 2022 introduced the Dutyholder Regime, which applies to all building work subject to building control under the Building Regulations 2010 (as amended), not just Higher-Risk Buildings (HRBs). It places legal responsibilities on clients, building owners, principal designers, and principal contractors to ensure compliance with Building Regulations and maintain accurate records, including the Golden Thread of information.

The roles of Building Regulations Principal Designer and Principal Contractor under the Act are distinct from those under CDM 2015 (the Construction (Design and Management) Regulations 2015). While responsibilities may overlap, they must be clearly defined in formal appointments to avoid liability risks.

The Building Safety Regulator (BSR) can enforce these duties with broad powers, including investigations, notices, and court applications. Its first emergency injunction at Deakins Yard, a student accommodation project, prevented occupation until compliance was achieved, setting a strong precedent for enforcement under the new regime.

Emerging Risk for Contractors, Consultants, and Insurers

The BSR’s injunction at Deakins Yard signals a significant shift in potential liabilities for Dutyholders, introducing the potential for an additional head of loss where the financial consequences of non-compliance could be severe. In sectors such as student accommodation or commercial premises, delays in selling or leasing developments can result in substantial losses.

Dutyholders now face heightened exposure following the recent judgment in respect of any developments that fail to comply with Building Regulations. 

Where occupation of new buildings or remediated buildings are prohibited by an injunction, contractors, sub-contractors, and consultants may face claims with new or far greater measures of loss and damages than anticipated. As set out above, claims for loss of profit or rent; loss of opportunity; or liquidated and ascertained damages can quickly extend beyond the direct costs of remediating the alleged defects. 

Existing claims where negotiations are ongoing, but ‘building work’ has not yet commenced may require reassessment given the potential for additional losses arising from BSR scrutiny. A common example that we are seeing is in relation to complex claims which were first commenced by building owners before the Grenfell Fire, c. 7 years ago. During the intervening period, the issues complained of – as well as potential remedial solutions – have evolved. There are therefore a significant number of developments across the UK where there are known issues but no definitive remedial scheme and/or settlement agreement. It is therefore entirely possible that the BSR’s views could differ from the relevant parties that have spent potentially years investigating and have multiple experts’ inputs.

Conclusion

Contractors, sub-contractors, consultants, and their insurers must therefore recognise that the BSR not only holds these powers but is prepared to proactively exercise them. The potential impact of a development remaining vacant while compliance issues are resolved would be significant.  

It is therefore paramount that, in respect of any claims (whether new or existing), rigorous attention is given to remedial schemes and/or settlement strategies to mitigate the risk of potential BSR intervention.

If you have any questions in relation to the BSR or Dutyholder liabilities, please do not hesitate to contact Clyde & Co. 

What trends and challenges do you see on the horizon for construction professionals? We’d love to hear from you.

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SHANGHAI, Dec. 9, 2025 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, announced new data from its hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include golidocitinib, a Janus kinase 1 (JAK1) only inhibitor, in T-cell lymphoma, and birelentinib, a non-covalent LYN/BTK dual inhibitor, in B-cell lymphoma.

Golidocitinib

Two dose regimes of golidocitinib combined with CHOP have been explored for the treatment of newly diagnosed PTCL. Both demonstrated promising antitumor activities and a manageable safety profiles.

• • Golidocitinib 75mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 94.1% and a CR rate of 64.7%. By the data cutoff date, 85% of patients remained on treatment.
  • Golidocitinib 150mg daily with CHOP, followed by 150mg maintenance after CHOP, showed an ORR of 88.9% and a CR rate of 61.1%
     
• R/R PTCL

An updated 2-year follow-up from the MD Anderson Cancer Center cohort of the multinational pivotal trial JACKPOT8 Part B showed that golidocitinib monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) achieved an objective response rate (ORR) of 53.8% and a complete response (CR) rate of 46.1%. Median progression-free survival (PFS) was 37.9 months and the 2-year PFS rate was 58.3%. The research findings validated golidocitinib’s long-lasting efficacy and tolerability in the U.S. patient population.

Golidocitinib monotherapy demonstrated compelling clinical activity with a favorable safety profile in heavily pretreated relapsed or refractory T-cell and NK-cell large granular lymphocyte leukemia (r/r T-LGLL) patients. Results from a prospective study showed an ORR of 92.3% and a CR rate of 61.15%. Additionally, the study reported a 100% response among STAT3-wildtype patients.

A Phase II clinical study showed that golidocitinib in combination with CHOP demonstrated profound antitumor activity in treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). The ORR was 85.7% and the CR rate was 71.4%, demonstrating a significant therapeutic advance over conventional chemotherapy.

In r/r PTCL-associated hemophagocytic lymphohistiocytosis (HLH), golidocitinib-based regimens demonstrated dual anti-HLH and antitumor efficacy, with rapid clinical improvement and an ORR of 46.7%. Most patients achieved systemic and hematologic recovery with a manageable safety profile. These findings highlight the potential of JAK1 inhibition in this high-risk disease.

Birelentinib

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a malignancy originating from mature B-cell non-Hodgkin lymphoma (B-NHL). While Bruton’s tyrosine kinase (BTK) inhibitors have transformed the treatment of B-cell lymphomas, resistance remains a significant challenge. Two primary types of resistance mutations have been identified after BTK inhibitor treatment for B-NHL: BTK-dependent and non-BTK pathway-mediated resistance. Although the BTK-dependent resistance is well-characterized, the emergence of kinase-impaired BTK mutations underscores the increasingly recognized role of non-BTK pathways.

Birelentinib is designed to block both BTK-dependent and BTK independent BCR signaling. Building upon promising data presented orally at the 2025 ASCO Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML), updated follow-up data of birelentinib reported at this ASH Annual Meeting demonstrated potent anti-tumor efficacy with a manageable safety profile in heavily pre-treated CLL/SLL patients.

At 50 mg QD (RP3D), birelentinib achieved an ORR of 84.2%. Tumor responses were observed irrespective of prior BTK inhibitor, BCL-2 inhibitor or BTK degrader treatment, and in patients with kinase-proficient or kinase-impaired BTK mutation. Antitumor efficacy proved durable, with no new safety concerns identified during follow-up.

Based on the encouraging results, birelentinib has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The global multicenter Phase III study in r/r CLL/SLL is currently ongoing.

About Golidocitinib (DZD4205)

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About Birelentinib (DZD8586)

Two resistance mechanisms have been found in patients whose diseases have progressed on a BTK inhibitor treatment: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed to treat both BTK-dependent and BTK-independent B-cell non-Hodgkin lymphoma (B-NHL).

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio. ZEGFROVY is the first and only small molecule drug approved in both the U.S. and China, for the treatment of non-small cell lung cancer with EGFR exon20 insertion mutations. Golidocitinib has been approved in China for the treatment of relapsed and refractory PTCL. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or X.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, and “intend” and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

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SOURCE Dizal Pharmaceutical