YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 372 drug applications between 22 March 2025 and 28 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 61 drug names.
2025/03/22 – 2025/03/28
- New acceptances this week
- 372
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- 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
372filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 86 |
| New drug | 50 |
| Import | 41 |
| Import re-registration | 8 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 252 |
| Therapeutic biologic | 61 |
| TCM | 53 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 4 | 4 | 51 |
| 2 | Upadacitinib Sustained-release Tablets | 4 | 2 | 43 |
| 3 | Sodium Nitroprusside Injection | 3 | 3 | 15 |
| 4 | Diclofenac Diethylamine Emulgel | 3 | 2 | 20 |
| 5 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 6 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 7 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 8 | Apalutamide Tablets | 2 | 2 | 18 |
| 9 | Calcitriol Injection | 2 | 2 | 0 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Amgen Inc. | 9 | 3 | 0 |
| 3 | Roche Pharma(Schweiz)AG | 8 | 1 | 0 |
| 4 | Eli Lilly and Company | 7 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 6 | 2 | 0 |
| 8 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Sanofi Winthrop Industrie | 5 | 2 | 0 |
| 10 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized | 4 | 4 | 4 |
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
119 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/28Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500038 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/28Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500037 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/28Import · Class 1 | Empasiprubart注射用浓溶液 · No verified English nameJXSL2500047 | argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd. |
| 2025/03/28Import · Class 1 | PF-07985045片 · No verified English nameJXHL2500066 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/03/28Import · Class 1 | PF-07985045片 · No verified English nameJXHL2500065 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500064 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500063 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500062 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500061 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500060 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500059 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Generic · Class 3 | Epinastine Hydrochloride Eye DropsCYHS2501218 | Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2025/03/28Generic · Class 3 | Famotidine InjectionCYHS2501216 | Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized |
| 2025/03/28Generic · Class 3 | Famotidine InjectionCYHS2501215 | Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized |
| 2025/03/28Generic · Class 3 | Dyclonine Topical SolutionCYHL2500073 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/28Generic · Class 3 | 溴莫尼定凝胶 · No verified English nameCYHL2500072 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/28New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500026 | Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized |
| 2025/03/28New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500025 | Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | DZD6008片 · No verified English nameCXHL2500342 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | DZD6008片 · No verified English nameCXHL2500341 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | DZD6008片 · No verified English nameCXHL2500340 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | AOD113408注射液 · No verified English nameCXHL2500339 | Chengdu Ao Da Bio Technology Co., Ltd. romanized |
| 2025/03/28New drug · Class 2.2 | WS-011 · No verified English nameCXHL2500337 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | EDP167注射液 · No verified English nameCXHL2500336 | Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | VVN432鼻喷雾剂 · No verified English nameCXHL2500335 | Wei Mou Bio Technology (Zhejiang) Co., Ltd. romanized |
| 2025/03/28New drug · Class 1 | VVN432鼻喷雾剂 · No verified English nameCXHL2500334 | Wei Mou Bio Technology (Zhejiang) Co., Ltd. romanized |
| 2025/03/28New drug · Class 2.3 | EP-0203XR · No verified English nameCXHL2500333 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 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. |
89 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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