AstraZeneca Pharma India Limited, a leading science-led biopharmaceutical company, has announced impressive financial results for the first quarter, demonstrating strong growth across its diverse therapy areas.

Financial Highlights

• Revenue: Increased by 36% to ₹5,263.10 million, up from ₹3,875.20 million in the same quarter of the previous year
• Net Profit: Returned to profitability with ₹558.30 million, compared to a loss of ₹117.90 million in the same quarter last year
• EBITDA: More than doubled to ₹811.00 million from ₹380.00 million year-over-year
• EBITDA Margin: Expanded significantly to 15.40% from 9.82% in the previous year's quarter

Therapy-wise Performance

The company's oncology segment showed remarkable growth, while the biopharmaceuticals segment experienced a slight decline. The rare disease segment, although small, doubled its revenue compared to the previous year.

Key Milestones and Approvals

AstraZeneca Pharma India has made significant strides in expanding its portfolio and strengthening its market position:

1. Received approval for Osimertinib tablets for an additional indication in non-small cell lung cancer (NSCLC) treatment.
2. Gained approval for trastuzumab deruxtecan for additional indications in HER2-low and HER2-ultralow metastatic breast cancer.
3. Obtained approval for Osimertinib as a monotherapy for locally advanced, unresectable (stage III) NSCLC.
4. Secured approval for Benralizumab as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

Management Commentary

Bhavana Agrawal, Chief Financial Officer & Director, commented on the results: "Our strong Q1 performance reflects the power of science-led innovation combined with disciplined execution. Each regulatory milestone brings us closer to transforming outcomes for patients living with chronic diseases."

Praveen Rao Akkinepally, Country President & Managing Director, added: "Delivering consistent growth across therapy areas reaffirms the strength of our Growth Through Innovation strategy and the passion of our teams to help more patients."

Recognition and Awards

AstraZeneca Pharma India's commitment to excellence has been acknowledged through various recognitions:

• OPPI Medical Excellence Award for Medical Affairs, Regulatory Excellence, and Clinical Trials
• 1st Place in the SAS Customer Recognition Awards for innovative use of Real-World Data in clinical trials
• Featured by Fortune India as a leading multinational transforming healthcare in India

As AstraZeneca Pharma India Limited celebrates its 45th year in India, the company continues to focus on expanding its portfolio, strengthening partnerships, and ensuring that breakthrough medicines reach patients who need them most. With a workforce of over 600 employees across the country, AstraZeneca remains committed to delivering innovative science and excellence in development and commercialization of life-changing medicines.

AstraZeneca Pharma India Limited has announced plans to introduce Eculizumab, marketed under the brand name Soliris, to the Indian market in August 2025. This strategic move marks a significant step in expanding the availability of this critical medication in India.

Background

Eculizumab is a concentrate for solution for infusion, containing 300 mg (10mg/ml) of the active ingredient. It is primarily indicated for the treatment of two rare but serious conditions:

1. Paroxysmal Nocturnal Hemoglobinuria (PNH)
2. Atypical Hemolytic Uremic Syndrome (aHUS)

The medication works by inhibiting complement-mediated thrombotic microangiopathy, a process involved in these diseases.

Regulatory Approval

The company's decision to launch Eculizumab follows a series of regulatory milestones:

• On January 16, 2025, AstraZeneca Pharma India received the Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Eculizumab.
• This approval paved the way for the company to introduce the medication to the Indian market.

Launch Details

In a communication to the BSE Limited and the National Stock Exchange of India Limited on August 6, 2025, AstraZeneca Pharma India confirmed its plans to launch Eculizumab (Soliris) in August 2025. This launch is expected to provide a new treatment option for patients in India suffering from PNH and aHUS.

Implications

The introduction of Eculizumab to the Indian market could potentially benefit patients with these rare but severe conditions. As a targeted therapy, it may offer hope to those who have limited treatment options for these life-threatening disorders.

AstraZeneca Pharma India's move to bring Eculizumab to India demonstrates the company's commitment to addressing unmet medical needs in the country. The launch of this specialized medication could also potentially strengthen the company's position in the rare disease treatment market in India.

As the launch date approaches, healthcare providers and patients alike will be watching closely to see how this new treatment option impacts the management of PNH and aHUS in India.