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Daily Pharma News - 22 October 2026

India's drug regulator had a busy day, with CDSCO clearing both an oncology breakthrough from Dr Reddy's and a first-of-its-kind haemophilia therapy from Sanofi. Beyond India, the day's headlines span a generic-access win for SMA children in Kerala, an antibody trial green light in China, a schizophrenia biosimilar-style study in Russia, and major US FDA decisions on a rare kidney drug and a generic hormone patch. Here is what every pharmacy student should know.

DCGI approves Dr Reddy's Zytorvi (toripalimab) for advanced esophageal cancer

The Drugs Controller General of India has approved Dr Reddy's Laboratories' Zytorvi (toripalimab) in combination with cisplatin and paclitaxel as first-line therapy for advanced esophageal squamous cell carcinoma (ESCC). This is the second indication for the PD-1 checkpoint inhibitor in India, following its earlier oncology approval.

The approval rests on data from the JUPITER-06 Phase 3 trial, which showed that adding toripalimab to platinum-based chemotherapy significantly improved outcomes in treatment-naive advanced ESCC. Esophageal cancer carries a high burden in parts of India, and PD-1 inhibitors like toripalimab work by blocking the programmed death-1 receptor, restoring T-cell responses against tumour cells - a mechanism pharmacy students should compare with other approved PD-1 drugs such as pembrolizumab and nivolumab. The arrival of an approved Indian option brings immunotherapy-chemo combinations within reach of more oncology centres.

Sanofi's Qfitlia (fitusiran) gets CDSCO nod for haemophilia A and B

The CDSCO has authorised Sanofi's Qfitlia (fitusiran) for bleeding prophylaxis in patients aged 12 and above with haemophilia A or B, with or without inhibitors. Fitusiran is a first-in-class small interfering RNA (siRNA) therapy that lowers antithrombin levels, rebalancing the coagulation cascade so that blood clots more effectively - a clever indirect approach to a disease of missing clotting factors.

What makes Qfitlia especially interesting for pharmacy practice is the dosing: just six subcutaneous injections a year. It is backed by the ATLAS Phase 3 programme, and its benefit in patients with inhibitors - who cannot be helped by conventional factor replacement - addresses one of the toughest unmet needs in haemophilia care. Students of pharmacology should note how RNA interference, a concept from molecular biology, is now a licensed therapeutic class reshaping chronic disease management.

Kerala defends switch to generic risdiplam for spinal muscular atrophy in children

Health experts have backed the Kerala government's switch to an approved generic version of risdiplam (marketed as Evrysdi) for treating spinal muscular atrophy (SMA) in children, calling the controversy over the change unwarranted. The state's health minister said concerns about the switch were misplaced, noting that the generic is already used by premier hospitals.

Risdiplam is an orally administered SMN2 splicing modifier that increases functional SMN protein, making it a life-changing therapy for a devastating neuromuscular disease - but the innovator product is notoriously expensive. Kerala's move is a textbook case of how generic substitution can widen access to rare-disease therapies in a resource-constrained public health system, while keeping safety and efficacy anchored to CDSCO-approved standards. For pharmacy students, this is a live example of the access-versus-innovation tension that defines pharmaceutical policy.

NMPA clears Bao Pharma's BJ045, a subcutaneous anti-CD20 antibody for autoimmune diseases

China's National Medical Products Administration has approved the Investigational New Drug (IND) application for Bao Pharma's BJ045, a subcutaneous anti-CD20 monoclonal antibody for autoimmune diseases. The molecule is engineered to resist IgG-degrading enzymes and is co-formulated with hyaluronidase, which disperses the injection site matrix and allows larger antibody doses to be delivered under the skin.

This is a neat formulation-pharmacology story: moving biologics from intravenous infusion to subcutaneous delivery improves patient convenience and cuts clinic burden. Anti-CD20 antibodies such as rituximab and ocrelizumab are established in autoimmune and oncologic indications, so BJ045 slots into a competitive but innovation-hungry space. Students should watch how hyaluronidase-enabled subcutaneous biologics - already used in drugs like trastuzumab and rituximab formulations - become a standard platform across the industry.

Russia approves bioequivalence study of Akrikhin's schizophrenia drug candidate

Russia's Health Ministry has authorised Akrikhin to conduct a bioequivalence study of RND122500, its xanomeline/trospium combination candidate for schizophrenia. The combination mirrors Bristol Myers Squibb's Cobenfy, which the US FDA approved in 2024 - the first new schizophrenia drug class in decades.

Xanomeline is a muscarinic M1/M4 receptor agonist, a completely different pharmacology from the dopamine-D2 blockade of traditional antipsychotics, while trospium is a peripherally acting anticholinergic added to blunt the muscarinic side effects. This story is a goldmine for pharmacology revision: students can contrast direct central muscarinic agonism with decades of dopaminergic antipsychotic therapy, and note how bioequivalence studies - the regulatory backbone of generic development - follow ICH principles in every major market including Russia.

FDA grants accelerated approval to AstraZeneca's Ultomiris (ravulizumab) for IgA nephropathy

The US FDA has granted accelerated approval to AstraZeneca's Ultomiris (ravulizumab) to reduce proteinuria in adults with IgA nephropathy, a rare immune-mediated kidney disease. Ravulizumab, a long-acting complement C5 inhibitor, cut proteinuria by 43.4% at 34 weeks in clinical testing.

Accelerated approval allows a drug to reach patients earlier on the basis of a surrogate endpoint - here, proteinuria reduction - with confirmatory evidence of clinical benefit required later. Ravulizumab binds complement protein C5, preventing formation of the membrane attack complex and reducing kidney inflammation; it is already approved for paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. Pharmacy students should file this alongside complement biology as one of the fastest-growing frontiers in immunopharmacology.

Zydus wins US FDA nod for generic hormone patch with 180-day exclusivity

Zydus has secured US FDA final approval for its generic of Bayer's Climara Pro transdermal patch (estradiol/levonorgestrel) for menopause symptoms, with Competitive Generic Therapy (CGT) designation and 180-day market exclusivity. The transdermal route avoids first-pass metabolism, delivering steady hormone levels - a formulation advantage that makes generic development technically demanding.

This is a showcase of Indian generic industry strength: transdermal systems are among the hardest dosage forms to replicate bioequivalently, so CGT exclusivity is both a reward and a competitive moat. For students of pharmaceutics, patches are a perfect case study in controlled drug delivery - permeation enhancers, adhesive matrices, and release kinetics - while the 180-day exclusivity demonstrates how regulatory incentives drive complex generics.

Conclusion

Today's news tells one overarching story: pharmacology's frontiers are moving from symptomatic treatment to precision intervention. From PD-1 immunotherapy in esophageal cancer and siRNA in haemophilia to complement inhibition in kidney disease and muscarinic agonism in schizophrenia, new mechanisms are reshaping disease management across therapeutic areas. At the same time, the Kerala generic switch and Zydus's CGT win show that access and affordability remain as important as innovation - and that India sits at the centre of both.

For pharmacy students, this is a day to connect classroom theory with the real world: map each mechanism to the receptor and pathway you have studied, and ask how the drug-delivery route (subcutaneous, transdermal, oral) shapes its success. Tomorrow's formulary is being written today - and understanding it starts now.

References

  1. The Hindu BusinessLine - DCGI approves Dr Reddy's Zytorvi for advanced esophageal cancer https://www.thehindubusinessline.com/companies/dr-reddysgets-dcgis-nod-for-zytorvi/article71606282.ece
  2. The Hindu BusinessLine - Sanofi's Qfitlia gets CDSCO nod for haemophilia A and B https://www.thehindubusinessline.com/companies/sanofi-gets-cdsco-nod-for-drug-to-prevent-bleeding-in-haemophilia-patients/article71607340.ece
  3. The Hindu - Kerala defends switch to generic risdiplam for SMA children https://www.thehindu.com/news/national/kerala/row-over-sma-drug-distribution-in-keralam-unwarranted-say-experts/article71607610.ece
  4. Minichart - NMPA clears Bao Pharma's subcutaneous anti-CD20 antibody trial https://www.minichart.com.sg/2026/10/21/bao-pharma-wins-nmpa-ind-approval-for-subcutaneous-anti-cd20-antibody-bj045/
  5. GxP News - Russia approves bioequivalence study of Akrikhin schizophrenia drug https://gxpnews.net/en/2026/10/russia-approves-bioequivalence-study-of-akrikhins-schizophrenia-drug-candidate/
  6. Securities.io - FDA gives accelerated approval to Ultomiris for rare kidney disease https://www.securities.io/fda-clears-ultomiris-for-proteinuria-reduction-in-adults-with-igan/
  7. The Hindu - Zydus wins US FDA nod for generic hormone patch https://www.thehindu.com/business/Industry/zydus-generic-of-hormone-therapy-patch-gets-us-fda-nod/article71607420.ece

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