YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 328 drug applications between 20 March 2025 and 26 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 69 drug names.
2025/03/20 – 2025/03/26
- New acceptances this week
- 328
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 23
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
328filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 160 |
| Generic | 92 |
| New drug | 35 |
| Import | 25 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 49 |
| Therapeutic biologic | 49 |
| Prophylactic biologic | 6 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Nitroprusside Injection | 3 | 3 | 15 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 3 | Mupirocin Ointment | 3 | 1 | 30 |
| 4 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 5 | 氧(气态) · No verified English name | 2 | 2 | 1 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Sodium Iodide[131I] Oral Solution | 2 | 2 | 2 |
| 8 | Calcitriol Injection | 2 | 2 | 0 |
| 9 | Canagliflozin Tablets | 2 | 1 | 8 |
| 10 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 10 | 2 | 0 |
| 2 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Roche Pharma(Schweiz)AG | 8 | 1 | 0 |
| 4 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Hubei Wu Shi Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Sanofi Winthrop Industrie | 5 | 2 | 0 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 8 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Celgene Corporation | 4 | 1 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 4 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/26Import · Class 1 | DS-1062a · No verified English nameJXSL2500045 | ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited |
| 2025/03/26Import · Class 1 | AZD2936 · No verified English nameJXSL2500044 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/03/26Generic · Class 3 | 罗沙司他片 · No verified English nameCYHS2501188 | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2025/03/26Generic · Class 3 | 盐酸伊立替康脂质体注射液 · No verified English nameCYHS2501187 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/03/26Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2501182 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/26Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501180 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/03/26Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501176 | Shanxi Jiu Kang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/03/26Generic · Class 3 | Ketoprofen PatchesCYHL2500071 | Beijing Foyou Pharma CO.,LTD |
| 2025/03/26Generic · Class 3 | Ketoprofen PatchesCYHL2500070 | Beijing Foyou Pharma CO.,LTD |
| 2025/03/26Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500067 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2025/03/26Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHL2500066 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | 注射用SSGJ-705 · No verified English nameCXSL2500247 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/03/26New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500246 | Beijing Bo Te Wei Ke Bio Technology Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | 注射用BC2027 · No verified English nameCXSL2500245 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2025/03/26New drug · Class 2.2; 2.4 | 硫酸镁无菌溶液 · No verified English nameCXHL2500326 | Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | RO7673396薄膜包衣片 · No verified English nameCXHL2500325 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | RO7673396薄膜包衣片 · No verified English nameCXHL2500324 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | RO7673396薄膜包衣片 · No verified English nameCXHL2500323 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | WSD0922-FU片 · No verified English nameCXHL2500322 | Hangzhou Wei Rui Bao Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | WSD0922-FU 片 · No verified English nameCXHL2500321 | Hangzhou Wei Rui Bao Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | JZ-14胶囊 · No verified English nameCXHL2500320 | Yun Bai Yao Zheng Wu Technology (Shanghai) Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | JZ-14胶囊 · No verified English nameCXHL2500319 | Yun Bai Yao Zheng Wu Technology (Shanghai) Co., Ltd. romanized |
| 2025/03/26New drug · Class 1 | SVHRSP注射液 · No verified English nameCXHL2500318 | Shenyang Wan Jin Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/25Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2500043 | Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd |
| 2025/03/25Import · Class 1 | AZD2936 · No verified English nameJXSL2500042 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500041 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500040 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500039 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Generic · Class 3 | Hydrotalcite SuspensionCYHS2501173 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2501162 | Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
63 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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