YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 357 drug applications between 21 March 2025 and 27 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 62 drug names.
2025/03/21 – 2025/03/27
- New acceptances this week
- 357
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 25
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
357filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| Generic | 83 |
| New drug | 48 |
| Import | 30 |
| Import re-registration | 8 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| Therapeutic biologic | 58 |
| TCM | 53 |
| Prophylactic biologic | 7 |
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
62 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 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 3 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 4 | Mupirocin Ointment | 3 | 1 | 30 |
| 5 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 6 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 7 | Apalutamide Tablets | 2 | 2 | 18 |
| 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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Amgen Inc. | 8 | 2 | 0 |
| 3 | Roche Pharma(Schweiz)AG | 8 | 1 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hubei Wu Shi Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 8 | Sanofi Winthrop Industrie | 5 | 2 | 0 |
| 9 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 10 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/27Import · Class 2.1 | 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSL2500046 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/03/27Import · Class 1 | TPST-1120片 · No verified English nameJXHL2500058 | Tempest Therapeutics Inc.; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2025/03/27Import · Class 2.4 | Megestrol Acetate Oral SuspensionJXHL2500056 | TWi Pharmaceuticals Inc.; Changchun GeneScience Pharmaceuticals Co. Ltd. |
| 2025/03/27Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501201 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/03/27Generic · Class 3 | Ferrous Succinate TabletsCYHS2501200 | Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2025/03/27Generic · Class 3 | Ferrous Succinate TabletsCYHS2501199 | Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized |
| 2025/03/27Generic · Class 3 | Bumetanide InjectionCYHS2501196 | Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2025/03/27Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2501195 | Shanghai Qing Ping Pharma Co., Ltd. romanized |
| 2025/03/27New drug · Class 3.1 | 桃核承气汤颗粒 · No verified English nameCXZS2500012 | Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized |
| 2025/03/27New drug · Class 2.3 | 肺热咳喘颗粒 · No verified English nameCXZL2500020 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/03/27New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2500252 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | HD006细胞 · No verified English nameCXSL2500251 | Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/27New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2500250 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | Cizutamig注射液 · No verified English nameCXSL2500249 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | 注射用人白介素-2(高亲和型复合物) · No verified English nameCXSL2500248 | Beijing Liang Yuan Biopharmaceuticals Research Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | BW-40202注射液 · No verified English nameCXHL2500338 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | CPI-818片 · No verified English nameCXHL2500332 | Jia Xing He Ji Pharma Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | CPI-818片 · No verified English nameCXHL2500331 | Jia Xing He Ji Pharma Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | WJ47156片 · No verified English nameCXHL2500330 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | WJ47156片 · No verified English nameCXHL2500329 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/27New drug · Class 2.2 | ZL-0018 · No verified English nameCXHL2500328 | Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/27New drug · Class 1 | JKN2301干混悬剂 · No verified English nameCXHL2500327 | Health Yuan Pharma Group Co., Ltd. romanized |
| 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 |
73 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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