Healthcare & Life Sciences News & Trends: Dec Week 3
Healthcare & Life Sciences News & Trends: Dec Week 3
1. Market Regulations
NMPA Streamlines the Approval Process for Oral TCMs
The National Medical Products Administration (NMPA) in China released a draft policy aimed at streamlining the approval process for traditional oral Chinese medicines (TCMs) already registered in Hong Kong and Macau to enter the mainland market. Key points include:
- Significant Time Reduction: The review timeline for eligible TCMs will be shortened from 200 working days to 80 days.
- Eligibility Criteria: Products must
- Be owned by manufacturers registered in Hong Kong or Macau.
- Have been approved and used in these regions for over 15 years.
- Adhere to Good Manufacturing Practice (GMP) standards.
- Application Requirements:
- Applications must be filed by a mainland-based legal entity.
- Data from the original Hong Kong/Macau registration can be reused.
- Applicants must summarise 15 years of user experience and provide any available clinical or non-clinical safety data recognised by Hong Kong/Macau regulators.
Takeaway: The policy creates a streamlined pathway for Hong Kong and Macau oral TCMs to enter the mainland market, potentially increasing product variety and market competition. If implemented, this policy will foster integration between the TCM markets of Hong Kong, Macau, and mainland China. It presents opportunities for Hong Kong and Macau manufacturers to capture the vast potential of the mainland market while enhancing competition and innovation in the TCM sector.
2. Licencing Deals
i. Merck Buys Global Rights for Hansoh’s GLP-1 Obesity Pill
Merck has entered a high-stakes market for obesity treatments with a $2 billion deal to acquire global rights to a promising oral GLP-1 receptor-targeting drug (HS-10535) from Chinese firm Hansoh Pharmaceutical.
- Deal Details: The deal includes $112 million upfront and $1.9 billion in potential milestone payments. Hansoh will earn royalties on sales and may co-promote or exclusively market the drug in China under specific conditions.
Takeaway: This strategic move aligns with Merck’s focus on advancing second- and third-generation obesity and cardiometabolic treatments, complementing their broader portfolio in diabetes and related diseases. While the pill is still in preclinical development, it may potentially provide a convenient oral alternative to existing injectable therapies.
The transaction reflects the growing momentum around GLP-1 therapies globally, evidenced by similar deals from AstraZeneca and others.
ii. BMS Secures Rights to BioArctic’s Alzheimer’s Prospects
Bristol Myers Squibb (BMS) acquired global rights to two preclinical antibody candidates (BAN1503 and BAN2803) from BioArctic.
- Deal Value: The deal is worth $100 million upfront, with additional potential payments of up to $1.25 billion.
- Details: These antibodies target pyroglutamate-amyloid-beta, a key focus in Alzheimer’s research. Notably, BAN2803 leverages BioArctic’s BrainTransporter technology to cross the blood-brain barrier (BBB) and improve delivery to deeper brain structures. This technology aims to enhance therapeutic efficacy and safety by increasing brain exposure while reducing dosing requirements.
Takeaway: The move follows BMS’s $14 billion acquisition of Karuna Therapeutics.
iii. CSPC Secures Rights to BeiGene’s MAT2A Inhibitor
CSPC Pharmaceutical Group entered a licensing agreement with BeiGene for its novel MAT2A inhibitor, SYH2039.
- Deal Value: CSPC will receive $150 million upfront, up to $135 million in development milestones, and $1.55 billion in potential commercial milestones, plus tiered royalties. Meanwhile, the deal grants BeiGene global rights for SYH2039’s development and commercialisation.
- Details: SYH2039 is a product of CSPC’s AI drug discovery platform, and it has demonstrated promising preclinical efficacy across multiple cancer types.
Takeaway: This marks CSPC’s second high-profile AI-driven out-licensing deal within months, following a similar agreement with AstraZeneca for a preclinical Lp(a) inhibitor.
- Strategic Implications: The MAT2A inhibitors will complement BeiGene’s pipeline, particularly its PRMT5 inhibitor, BGB-58097, with potential synergy in combination therapies. It also aligns with BeiGene’s focus on advancing innovative oncology treatments in global markets.
- Market Impact:
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- SYH2039’s discovery via CSPC’s collaboration with AI platforms like Insilico Medicine and XtalPi underscores the accelerating role of AI in drug development.
- As the first pharma company to operationalise AI-enabled drug discovery for multiple licensing deals (“batch BD model”), CSPC also sets a benchmark for global pharma players.
- CSPC’s success exemplifies the transition of traditional pharmaceutical companies from generic production to innovation-driven pipelines. This trend is poised to reshape the landscape, enabling faster, cost-effective drug discovery and commercialisation.
iv. Sanofi Acquires China Rights to Cytokinetics’ Cardiac Myosin Med
Sanofi acquired exclusive rights for Cytokinetics’ cardiac myosin inhibitor, aficamten, in Greater China.
- Deal Value: Cytokinetics will receive up to $150 million in milestone payments and royalties from Sanofi, alongside additional undisclosed payments tied to the Corxel deal.
- Details: Aficamten is under priority review in China for obstructive HCM (oHCM) and awaits approval in the US (decision due September 2025) and Europe. Phase 3 data demonstrate aficamten’s superior efficacy compared to placebo in improving exercise capacity for oHCM patients, with potential to rival Camzyos. The rights were transferred from Corxel Pharmaceuticals, which previously held a regional licensing deal with Cytokinetics.
Takeaway: This acquisition complements Sanofi’s broader investment in China, which includes a $1 billion manufacturing site focused on insulin production. Notably, Sanofi isn’t the first major pharmaceutical company to back aficamten. In November, Bayer secured licensing rights to the drug in Japan with an upfront payment of €50 million. As part of the agreement, Bayer will conduct a phase 3 trial of aficamten in Japanese patients with obstructive HCM, while Cytokinetics will extend its global study of the drug to include Japan.
3. Business Moves
i. Lilly’s Zepbound Gets Landmark FDA Approval for OSA
Eli Lilly secured a landmark second FDA approval for its blockbuster drug Zepbound (tirzepatide). This makes it the first prescription treatment for adults with moderate to severe obstructive sleep apnoea (OSA) and obesity. The milestone expands the tirzepatide franchise, which is already approved for type 2 diabetes (as Mounjaro) and obesity.
- Clinical Results: In phase 3 trials, Zepbound demonstrated a 62.8% reduction in OSA severity and enabled significant weight loss, averaging 18–20% body weight reduction in patients.
- Future Plans: Tirzepatide is also being tested for other cardiometabolic conditions, including heart failure, prediabetes, and fatty liver disease (MASH).
- Competitive Edge: Zepbound outperformed its main rival in weight loss outcomes (20.2% vs. 13.7% over 72 weeks), reinforcing its position in the obesity market.
Takeaway: This approval can accelerate Lilly’s growth trajectory and diversify its pipeline while addressing the significant unmet need in OSA—a condition often overlooked but with broad implications for health and quality of life. However, the approval does include a warning for potential thyroid-related side effects, emphasising the need for patient monitoring.
ii. Perennial to Manage China’s First Fully Foreign-Owned Hospital
Perennial Holdings is set to operate China’s first wholly foreign-owned tertiary general hospital, the Perennial General Hospital Tianjin. This 500-bed facility adopts an asset-light co-medical space concept and is a key milestone enabled by China’s recent policy shift that allows foreign-owned hospitals in nine major regions.
Takeaway: Perennial’s model supports partnerships with medical groups and professionals. Meanwhile, the facility is part of a medical cluster comprising four hospitals and four new hotels. Together, this can help Perennial form an ecosystem that positions it as a pivotal player in the growing private healthcare market.
iii. XGEN Secures $190m Fund to Back Early-Stage Biotech and Medtech
Italian venture capital firm XGEN Venture closed its first €180 million fund focused on early-stage biotech and medtech companies. The fund has already supported six startups, including notable investments in Genespire (Italian gene therapy, $52 million Series B) and iOnctura (Merck KGaA cancer spinout). Over the next three years, XGEN plans to make nine additional investments to complete its portfolio.
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