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CMS (867.HK; 8A8.SG): NDA for the Seasonal Allergic Rhinitis Indication of Class 1 Innovative Drug MG-K10 Accepted in China

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SHENZHEN, CHINA – China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that the New Drug Application (NDA) in China for the Seasonal Allergic Rhinitis (SAR) indication of MG-K10 (generic name: Comekibart Injection, “MG-K10” or the “Product”), a Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection, for which the Group holds co-development rights (excluding the indication of atopic dermatitis (AD)) and exclusive commercialization rights, was accepted by the National Medical Products Administration of China (NMPA) on 23 April 2026. The Product is proposed for the treatment of adult patients with moderate-to-severe seasonal allergic rhinitis whose symptoms remain inadequately controlled after treatment with intranasal corticosteroids.

The acceptance of the NDA represents an important milestone for the Group’s ophthalmology business, CMS Vision, as it expands its therapeutic focus from ophthalmology into the field of otolaryngology (ENT). It also marks another significant milestone in the Group’s research and development progress in the field of type 2 inflammatory diseases. If the Product is successfully approved for marketing, the Group will leverage its strong academic promotion capabilities and extensive commercialization network to accelerate the commercialization of the Product. It is also expected to further enhance the academic brand influence of CMS Vision in the relevant specialty areas and provide new momentum for the Group’s business growth.

BIC Potential: Dosing once every 4 weeks; Phase III study met the primary endpoint with a favorable safety profile

MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling pathways of the key type 2 inflammatory cytokines IL-4 and IL-13, thereby exerting immunomodulatory effects. It is being developed for the treatment of type 2 inflammatory diseases, including seasonal allergic rhinitis, asthma, atopic dermatitis (AD), prurigo nodularis, chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Currently marketed anti-IL-4Rα therapies require administration once every two weeks. MG-K10, with its longer half-life, enabling a once-every-four-weeks dosing regimen. It therefore has the potential to become the first long-acting anti-IL-4Rα monoclonal antibody to be marketed globally, with the potential to be best-in-class. MG-K10 has met the primary endpoint in a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial in adult patients with moderate-to-severe seasonal allergic rhinitis. The results of the Phase III study demonstrated that the primary endpoint achieved statistical significance, with significantly superior efficacy compared with the placebo group, and a favorable safety profile.

Focusing on Unmet Needs: ~250 million patients; 62% of moderate-to-severe patients remain inadequately controlled; long-acting breakthrough brings new treatment opportunities

Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa mediated by IgE, with type 2 inflammation as the core pathogenic mechanism. It occurs in susceptible individuals upon exposure to environmental allergens such as pollen and dust mites. In recent years, the prevalence of the disease in China has increased from 11.1% to 17.6%, affecting approximately 250 million people[1], among whom 52.2% are patients with persistent moderate-to-severe disease[2]. The disease burden is significant and has become an important public health issue. Current standard treatments, including intranasal corticosteroids and antihistamines, have notable limitations. 62% of patients with moderate-to-severe disease remain inadequately controlled[3]. Long-term use of intranasal corticosteroids may lead to adverse reactions such as epistaxis[4], while antihistamines are often associated with side effects such as drowsiness[5], indicating significant unmet clinical needs. As a biologic therapy targeting IL-4Rα, MG-K10 can block the type 2 inflammatory pathway at its source. Compared with currently approved biologics targeting the same pathway (which require dosing once every two weeks), MG-K10 achieves a differentiated breakthrough in dosing frequency with its long-acting property allowing administration once every four weeks, thereby significantly extending dosing intervals. This may help improve patient treatment adherence and reduce the time and economic burden associated with frequent hospital visits. The Product has the potential to provide a new treatment option for patients with moderate-to-severe disease who respond poorly to conventional therapies, thereby reducing the individual and socio-economic burden associated with the disease.

On 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement (“Agreement”) with Hunan Mabgeek Biotech Co., LTD and its subsidiary for MG-K10. In accordance with the Agreement and supplementary agreements, the Group has obtained the co-development rights (excluding AD) and exclusive commercialization rights for the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore; its subsidiary Dermavon Holdings Limited has obtained, through its subsidiary, the co-development rights (excluding AD) and exclusive commercialization rights for the Product in the field of dermatological indications in Mainland China.

 

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the Cardiovascular-Kidney-Metabolic/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.

Reference

  1. Cheng L, Chen J, Fu Q, et al. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018;10:300‑353.
  2. Zheng, Ming et al. “Clinical characteristics of allergic rhinitis patients in 13 metropolitan cities of China.” Allergy vol. 76,2 (2021): 577-581. doi:10.1111/all.14561
  3. White, P et al. “Symptom control in patients with hay fever in UK general practice: how well are we doing and is there a need for allergen immunotherapy?” Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology vol. 28,3 (1998): 266-70. doi:10.1046/j.1365-2222.1998.00237.x
  4. Rosenblut, A et al. “Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis.” Allergy vol. 62,9 (2007): 1071-7. doi:10.1111/j.1398-9995.2007.01521.x
  5. Bernstein, Jonathan A et al. “Allergic Rhinitis: A Review.” JAMA vol. 331,10 (2024): 866-877. doi:10.1001/jama.2024.0530

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

Media Contact

Brand: China Medical System Holdings Ltd.

Contact: CMS Investor Relations 

Email: ir@cms.net.cn

Website: https://web.cms.net.cn/en/home/

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Carziqo Brings A-DS Autonomous Delivery to San Francisco During Future Mobility Festival

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  • The company reports rising delivery demand as it positions autonomous logistics as a response to growing operating costs and the need for more efficient urban services.

SAN FRANCISCO, CA, Oct 03, 2026, ZEX PR WIRE — Carziqo says its A-DS autonomous delivery vehicles have begun operating in San Francisco, extending the company’s delivery business during the Carziqo Future Mobility Festival. The development comes as the company reports continued growth in delivery orders across its supported operations and sees increasing opportunities for autonomous technology in the movement of goods.

The San Francisco operation brings a practical focus to the October celebration: how intelligent mobility can support the everyday needs of businesses and consumers. For Carziqo, autonomous delivery represents an opportunity to connect its vehicle technology with a service whose value depends on consistency, convenience and careful management of operating costs.

The company’s recent announcements have emphasized rising A-DS order volumes and the importance of matching delivery demand with available fleet capacity. Carziqo says its priority is to translate that growth into better vehicle utilization and a more dependable service as the business develops.

The economic backdrop gives that objective particular relevance. According to the U.S. Bureau of Labor Statistics, compensation costs for private industry workers rose 3.3 percent in the year ending June 2026, including a 3.1 percent increase in wages and salaries. Although these figures cover private industry broadly, they provide context for the cost pressures businesses face when planning labor-intensive services.

For delivery operators, handling additional orders involves more than adding vehicles. It requires coordinating routes, staffing, vehicle availability and the time needed to complete each task. Higher demand creates a commercial opportunity, but the ability to serve that demand efficiently determines how much value the additional activity can generate.

Carziqo’s approach centers on reducing the manual driving requirements of supported delivery journeys while maintaining human involvement in fleet supervision, maintenance, customer support and situations requiring direct intervention. The company describes this division of responsibilities as a way to organize delivery work more efficiently as volumes increase.

That distinction is central to the business case for autonomous delivery. Automation can change how resources are allocated, but its usefulness depends on the performance of the wider service. A vehicle must be available when needed, assigned a suitable route and supported throughout its operating cycle.

Carziqo describes the A-DS platform as combining automated driving with route planning, connected vehicle monitoring and centralized operational support. Its fleet systems are designed to bring together information about vehicle condition, delivery progress, charging requirements and maintenance needs, helping teams coordinate the vehicles as a network.

For San Francisco, the significance of the deployment lies in applying that approach to local delivery needs. The commercial opportunity will depend on how effectively available capacity meets demand and how consistently the service performs within its operating scope. Those practical considerations give the expansion a business focus beyond the introduction of another autonomous vehicle model.

Carziqo has previously described a phased approach to A-DS deployment, with attention to route suitability, operational stability and service consistency. Experience gathered from its delivery operations is intended to inform improvements in dispatching, maintenance planning and future deployment decisions.

The Carziqo Future Mobility Festival places these developments within the company’s broader ambition to make intelligent transportation relevant to daily life. Held throughout October, the festival centers on greener mobility, connected services and the practical use of technology to improve how people and goods move through cities.

Autonomous delivery gives that theme an everyday point of connection. Behind each delivery is a person waiting for an item or a business fulfilling a customer’s request. The value of the technology ultimately rests on whether it can help complete those tasks reliably and make the service easier to manage.

The festival also provides an occasion to recognize the community supporting Carziqo’s development. In a separate A-DS announcement, the company introduced an additional Wednesday Performance Reward for eligible A-DS rental users, with amounts, claiming arrangements and eligibility governed by the terms published on its platform.

As the company develops its delivery business, its stated priorities include closer coordination between demand and vehicle deployment, management of operating costs and continued improvement of the service experience.

The San Francisco operation adds a new chapter to that effort during the Future Mobility Festival. With A-DS, Carziqo is positioning autonomous delivery as a practical part of its longer-term mobility ambitions—one whose progress will be measured through the everyday work of moving goods and serving customers.

For company information and official updates, visit www.carziqo.com.

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Brian Baldari on the Difference Between a Mentor and a Sponsor, and Why It Decides Promotions

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  • ResilExec® Coaching founder Brian Baldari, Pharm.D., MBA, on why senior leaders who have plenty of advice and no advocacy stall at the same level for years.

BRICK, N.J., Oct 03, 2026, ZEX PR WIRE — Most senior professionals have someone they go to for advice. Far fewer have someone who argues for them in a room they are not in. According to Brian Baldari, Pharm.D., MBA, founder of ResilExec® Coaching, that distinction accounts for a large share of stalled advancement among otherwise strong performers.

Baldari spent 24 years inside pharmaceutical, healthcare, and enterprise leadership organizations. He held five successive Director-level roles, moved from Director to Vice President and Senior General Manager in 18 months, and led the commercial launch of 14 brands. He now works with Associate Directors, Directors, Senior Directors, Executive Directors, and Vice Presidents inside pharmaceutical, healthcare, and enterprise IT organizations.

“A mentor talks to you. A sponsor talks about you,” Baldari says. “One of those changes your calendar. The other changes your title.”

Advice Is Not Advocacy

Mentorship is widely available and widely encouraged. Many organizations run formal programs for it. A mentor offers perspective, context, and guidance, and that guidance has real value early in a career when the primary gap is knowledge.

Sponsorship operates differently. A sponsor spends their own credibility on someone else. They put a name forward on a succession slate, defend a candidate during calibration, and accept the consequences if the bet does not pay off. That is a materially different act, and it is not something an organization can mandate.

“Leaders collect mentors because mentors are easy to ask for,” Baldari says. “Nobody feels awkward requesting advice. Asking someone to spend their reputation on you is a different conversation, and most people never have it.”

Where the Gap Shows Up

The gap becomes visible at the point where advancement decisions are made collectively. Calibration sessions and succession discussions involve people across multiple functions, many of whom have no direct experience of a given candidate’s work. In those rooms, a candidate is represented by whoever chooses to speak.

“If nobody in that room can describe what you do at enterprise scale, you are not in the conversation, regardless of your review,” Baldari says. “The decision is not made on the strength of your record. It is made on the strength of the description someone else gives of it.”

Baldari notes that this is where strong performers are most often surprised. Their performance ratings are high, their manager is supportive, and the outcome still does not change, because the people who influenced the decision were never engaged.

Sponsorship as a Variable

Sponsorship is one of five variables in Baldari’s Promotion Math™ framework, alongside Performance, Visibility, Narrative, and Timing. In his assessment, strong performers optimize the first variable and leave the remaining four unattended, then attribute the result to politics.

“Performance gets you noticed. Positioning gets you promoted,” Baldari says. “Sponsorship is the variable people find hardest to work on, because it requires asking for something rather than producing something.”

What Changes the Outcome

Baldari advises leaders to identify the specific individuals who will participate in the decisions that affect them, then assess honestly whether those individuals could describe their contribution without prompting. In most cases the answer is no, and that is the actionable finding.

From there the work is practical rather than social. It involves delivering value to those individuals rather than checking in with them, framing results at enterprise level rather than functional level, and showing up in forums where that work is visible to people beyond a direct reporting line.

“You do not recruit a sponsor by asking them to be one,” Baldari says. “You give them something worth putting their name next to, and you make sure they understand what it was.”

About Brian Baldari

Brian Baldari, Pharm.D., MBA, based in Brick, New Jersey, is the founder of ResilExec® Coaching and Resilient Performance Group LLC. He spent 24 years inside pharmaceutical, healthcare, and enterprise leadership organizations, held five successive Director-level roles, and advanced from Director to Vice President and Senior General Manager in 18 months. He led the commercial launch of 14 brands across rare and chronic disease categories, led an organization of more than 250 people, and has mentored more than 50 leaders across three continents. Through ResilExec Coaching, he helps Associate Directors, Directors, Senior Directors, Executive Directors, and Vice Presidents accelerate career growth through personalized executive coaching, leadership development, and strategic career positioning.

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Resilient Performance Group LLC

https://resilexec.com

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Timothy Caraboolad Publishes a Buyer’s Checklist for New-Build Condos in South Florida

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  • Real estate developer Timothy Caraboolad is releasing a set of questions first-time buyers should ask before putting money down on a new-build apartment in South Florida.

A market full of new buildings, and a lot of first-time buyers

Florida, USA, Oct 03, 2026, ZEX PR WIRE — South Florida has no shortage of new construction. Buildings go up fast, sales offices open before the concrete cures, and renderings promise more than any buyer can verify in a single walkthrough.

Timothy Caraboolad, a real estate developer and designer based in Palm Beach, Florida, has spent years on the other side of that process, building high-end custom homes through his firm Lad Design. He says the buyers who end up happiest are the ones who ask harder questions earlier, not the ones who fall for the best rendering.

“A sales gallery is designed to sell you a feeling,” he says. “Your job as a buyer is to slow that down and ask what you’re actually getting for the price.”

What to check before signing anything

Caraboolad points first-time buyers toward a few areas that matter more than finishes.

Construction quality behind the walls. Countertops and cabinetry are easy to judge. What is inside the walls is not. Caraboolad suggests asking who the general contractor is, how long they have built in the area, and whether the building uses concrete or wood-frame construction, since that affects sound, insurance, and long-term durability in a hurricane-prone region.

HOA fees and what they actually cover. New buildings often advertise low fees at launch that rise once amenities open and reserves get funded. “Ask for the projected budget once the building is fully occupied, not just the introductory number,” Caraboolad says. He recommends buyers ask specifically what percentage of the fee goes into reserves, since that determines whether the building can pay for a roof or a seawall repair without a special assessment.

Storm readiness. In South Florida, this is not optional. Buyers should ask about impact windows, generator backup for elevators and common areas, and flood elevation. Caraboolad says a building’s flood zone designation should be requested in writing, not estimated by a sales agent.

Parking and storage, spelled out. Some buildings sell parking as a deeded asset. Others assign it and can reassign it later. Caraboolad says this distinction matters more than most buyers realize until after closing.

Developer track record. A new building has no resale history to check. Caraboolad suggests buyers look at other projects the same developer has completed, not just renderings of the one being sold, and ask how those buildings have held up.

Timing the purchase

For pre-construction units, Caraboolad says the biggest risk is not price, it is timeline. Delays are common, and buyers should understand what happens to their deposit if the closing date slips.

“Get the outside date for completion in writing,” he says. “And ask what your options are if that date passes.”

He also encourages buyers to walk a finished unit in the same building, or a comparable one from the same developer, before relying on a model unit that may use upgraded finishes not included in the base price.

Why this matters for first-time buyers specifically

Caraboolad says first-time buyers face a particular disadvantage: they often do not know which questions are normal to ask, so they accept vague answers.

“An experienced buyer will push back on a soft answer about HOA reserves or insurance history,” he says. “A first-time buyer might just assume that’s how it works. It isn’t. You’re allowed to ask for documentation before you commit.”

His broader point is that a new building can be a strong investment in South Florida, but only when the buyer treats the sales process the same way a developer would: checking budgets, checking materials, and checking the people building it, before checking the view.

About Timothy Caraboolad

Timothy Caraboolad is an entrepreneur, real estate developer, and designer based in Palm Beach, Florida. He is the founder of Lad Design, a South Florida firm building high-end custom homes, and previously founded Arc Design, a luxury residential development and design firm in the Boston area. He holds a Bachelor’s Degree in International Business from Rollins College.

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