相关临床试验
4
1 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
1995
进行中（未招募）
1
25.0%
招募中
3
75.0%
- India's CGPDTM published Draft Guidelines for examination of pharmaceutical patent applications on September 4, 2026, inviting public comments before finalisation. - The draft rebuilds the examiner's framework around roughly two dozen judicial decisions, including the 2013 Novartis ruling and Delhi High Court judgments from 2024–2026. - Section 3(d) efficacy analysis is reinforced as a data-driven inquiry, with bioavailability clarified as a pharmacokinetic parameter rather than a direct measure of therapeutic efficacy. - New structured tests for novelty ("Seven Stambha") and inventive step, plus dedicated treatment of Markush and product-by-process claims, signal stricter prosecution standards.
- PH Kurien, India's Controller General of Patents, issued the country's first compulsory licence on 9 March 2012, allowing Natco Pharma to produce Bayer's cancer drug Nexavar. - The ruling slashed the monthly treatment cost from over ₹2.8 lakh to ₹8,800, a reduction of about 97%, dramatically improving access for kidney and liver cancer patients. - The Patent Office found Bayer had failed to "work" its patent in India and was reaching only about 2% of the estimated 88,000 patients who needed the drug. - No further compulsory licences have been granted since, which health activists attribute to sustained pressure from multinational pharmaceutical companies.
- Natco Pharma reported a consolidated net profit of ₹206.5 crore for Q1FY27, down sharply from ₹480.3 crore in the year-ago quarter. - Consolidated total revenue fell 43% year-on-year to ₹794.4 crore, driven largely by lower revenue from the specialty oncology product Lenalidomide. - Associate company Adcock Ingram contributed ₹84.3 crore in profit share, representing roughly 41% of total consolidated net profit. - The board approved exploring a fundraise of up to ₹2,000 crore and declared an interim dividend of ₹1.50 per equity share.
- Natco Pharma's June quarter consolidated net profit fell 57% year-on-year to ₹206.5 crore, driven by lower sales of generic cancer drug Lenalidomide. - Total revenue declined nearly 43% to ₹794.4 crore, with international formulations dropping to ₹477.1 crore from ₹1,120.9 crore a year earlier. - The company's board approved a ₹2,000-crore Qualified Institutional Placement (QIP) to fund acquisitions, supplementing ₹3,500 crore in internal cash reserves. - Natco raised its stake in associate Adcock Ingram Holdings to 49% and declared an interim dividend of ₹1.5 per equity share.
- Cellogen Therapeutics raised ₹20 crore ($2.4 million) from Kotak Alternate Asset Managers to advance its CAR-T clinical programs and expand gene therapy pipeline. - The biotech startup is developing bispecific, dual-antigen CAR-T therapy targeting two cancer markers simultaneously to reduce relapse rates compared to conventional single-target treatments. - Cellogen aims to make CAR-T therapies accessible by pricing treatments at $60,000-$70,000, significantly lower than current costs of $500,000-$700,000. - The company is preparing for Phase I human clinical trials in collaboration with CMC Vellore and operates a GMP-compliant manufacturing facility in Noida.
- India's Patents Act, 1970, through provisions like Section 3(d) and compulsory licensing (Sections 84, 92), systematically prioritizes public health access over pharmaceutical patent monopolies. - The landmark 2012 Bayer v. Natco compulsory license granted Natco Pharma the right to produce generic Nexavar, slashing the monthly cost by 97% from ₹2,80,000 to ₹8,800. - Section 3(d) blocks patent "evergreening" by requiring demonstrated therapeutic efficacy for new forms of known substances, upheld in the 2013 Novartis v. Union of India Supreme Court ruling. - India's pharmaceutical dominance faces a structural vulnerability: approximately 68% of Active Pharmaceutical Ingredients are imported from China, prompting government PLI schemes and bulk drug parks to restore domestic manufacturing.
- The Delhi High Court refused to restrain Natco Pharma from selling its Cyantraniliprole 10.26% OD insecticide, rejecting FMC Corp's injunction plea citing patent infringement. - Justice Mini Pushkarna ruled that Natco had established a credible defense by demonstrating the patent's vulnerability to challenge, with the FMC patent set to expire in less than two months. - The court found that the balance of convenience favored Natco, which had invested heavily in manufacturing infrastructure and regulatory compliance since launching the product in April 2025. - FMC's potential injuries were deemed purely monetary and adequately compensable by damages, while Natco was allowed to continue sales with mandatory disclosure of manufacturing and revenue data.
- Indian pharmaceutical companies including Hetero Labs, Cipla, Annora Pharma, and Natco Pharma have successfully won bids to supply generic drugs to Chinese hospitals through the country's volume-based procurement process. - Hetero Drugs and Cipla secured contracts to supply one billion tablets of Dapagliflozin, a diabetes medication that dominates China's small molecule drug market with sales exceeding 8 billion RMB ($1.14 billion). - The breakthrough represents a significant opportunity for Indian firms to penetrate China's pharmaceutical market, traditionally dominated by multinational companies, despite pricing pressures and competition from cost-advantaged local manufacturers.
- The Delhi High Court dismissed Roche's appeal against Natco Pharma, allowing the launch of a generic version of risdiplam for spinal muscular atrophy treatment. - Natco's generic version will be priced at ₹15,900 per bottle compared to Roche's ₹6.2 lakh, representing a 97% price reduction for this life-saving medication. - The ruling prioritizes public health access over patent protection, potentially enabling more patients to benefit from government support under India's National Policy for Rare Diseases. - Roche expressed disappointment with the decision and emphasized the importance of intellectual property protection for pharmaceutical innovation in India.
- Natco Pharma has launched generic Bosentan tablets (32 mg) for oral suspension in the US, securing 180-day market exclusivity as the first-to-file generic manufacturer. - The drug treats pulmonary arterial hypertension in pediatric patients aged 3 years and older, serving as a generic equivalent to Actelion's Tracleer tablets. - Lupin Ltd serves as the marketing partner for this product, which had estimated annual sales of USD 10 million in the US market according to recent industry data. - The launch represents a significant opportunity in the specialized pediatric PAH treatment market, addressing an important unmet need for affordable therapy options.
