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.

AstraZeneca Pharma India Limited has issued a formal clarification regarding recent news about US drug pricing, emphasizing that the company is not involved in the matter and that there is no material impact on its operations.

No Connection to US Pricing Negotiations

The pharmaceutical company stated that it is not engaged in any negotiations related to the news article that appeared on moneycontrol.com titled 'Trump Tariff News Live: GSK and AstraZeneca among top companies told to 'cut US prices or else'. AstraZeneca Pharma India made it clear that this news item does not pertain to their company, which is listed on the BSE Limited and National Stock Exchange of India Limited.

Regulatory and Legal Status

In its clarification to the stock exchanges, AstraZeneca Pharma India confirmed that there are no regulatory or legal proceedings initiated or ongoing in relation to this matter. The company also stated that it is not aware of any information or pending announcements that could have a bearing on its share price.

Commitment to Transparency

The clarification was issued in response to inquiries from both the BSE Limited and the National Stock Exchange of India Limited. AstraZeneca Pharma India reassured stakeholders of its continued adherence to obligations under the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Market Impact

While the news about US drug pricing has created buzz in the pharmaceutical sector, AstraZeneca Pharma India's swift clarification aims to dispel any misconceptions about its involvement. The company's proactive communication underscores its commitment to transparency and accurate market information.

This clarification serves to distinguish AstraZeneca Pharma India's operations from those of its global counterparts and reinforces the importance of clear communication in maintaining investor confidence in the face of international pharmaceutical industry news.