YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 335 drug applications between 27 February 2025 and 5 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 63 drug names.
2025/02/27 – 2025/03/05
- New acceptances this week
- 335
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 8
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
335filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 82 |
| New drug | 50 |
| Import | 14 |
| Import re-registration | 8 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 74 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 6 |
| Biologic | 1 |
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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Polidocanol Injection | 5 | 2 | 23 |
| 2 | Oxaliplatin Injection | 3 | 1 | 4 |
| 3 | Mupirocin Ointment | 2 | 2 | 30 |
| 4 | Acetylcysteine Granules | 2 | 1 | 4 |
| 5 | Lactulose Oral Solution | 2 | 1 | 34 |
| 6 | Ibrutinib Tablets | 2 | 1 | 0 |
| 7 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 8 | Baricitinib Tablets | 2 | 1 | 32 |
| 9 | Famotidine Injection | 2 | 1 | 8 |
| 10 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 24 | 22 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | Bayer AG | 8 | 1 | 0 |
| 4 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Guizhou San Ren Tang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Heilongjiang Han Hong Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Pfizer Inc. | 4 | 3 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/05Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2500034 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd. |
| 2025/03/05Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2500033 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2025/03/05Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2500032 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2025/03/05Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2500031 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2025/03/05Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2500030 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2025/03/05Import · Class 1 | PF-06821497片 · No verified English nameJXHL2500034 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2025/03/05Import · Class 1 | PF-06821497片 · No verified English nameJXHL2500033 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2025/03/05Generic · Class 3 | Terlipressin Acetate InjectionCYHS2500927 | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/03/05Generic · Class 3 | Fudosteine oral solutionCYHS2500925 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/05Generic · Class 3 | 美洛昔康纳米晶注射液 · No verified English nameCYHS2500924 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2025/03/05Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2500923 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized |
| 2025/03/05Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2500920 | Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/03/05New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2500199 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/03/05New drug · Class 2.2 | 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500250 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 2.2 | 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500249 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 2.2 | 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500248 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 2.2 | 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500247 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 2.2 | 利奥西呱胃滞留缓释胶囊 · No verified English nameCXHL2500246 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 1 | 奎斯诺片 · No verified English nameCXHL2500245 | Zhong Ke Nanjing Sheng Ming Health Gao Deng Research Institute romanized |
| 2025/03/05New drug · Class 1 | HS-10510片 · No verified English nameCXHL2500244 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/05New drug · Class 1 | HS-10510片 · No verified English nameCXHL2500243 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/04Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSS2500021 | Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd. |
| 2025/03/04Import · Class 1 | PIT565 · No verified English nameJXSL2500029 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/04Generic · Class 3 | Famotidine InjectionCYHS2500914 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Famotidine InjectionCYHS2500913 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2500910 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2025/03/04Generic · Class 3 | Aceclofenac TabletsCYHS2500909 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2500908 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500905 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2025/03/04Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500904 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
77 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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