YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 436 drug applications between 4 July 2025 and 10 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 78 drug names.
2025/07/04 – 2025/07/10
- New acceptances this week
- 436
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 90
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
436filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 109 |
| New drug | 88 |
| Import | 29 |
| Import re-registration | 8 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 302 |
| Therapeutic biologic | 69 |
| TCM | 62 |
| Prophylactic biologic | 2 |
| 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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 5 | 5 | 53 |
| 2 | Empagliflozin Tablets | 4 | 2 | 18 |
| 3 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 4 | Quetiapine Fumarate Extended-release Tablets | 4 | 1 | 0 |
| 5 | Acyclovir Tablets | 3 | 1 | 6 |
| 6 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 7 | Iguratimod Tablets | 2 | 2 | 23 |
| 8 | 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name | 2 | 2 | 2 |
| 9 | Finerenone Tablets | 2 | 2 | 69 |
| 10 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
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
263 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 17 | 14 | 0 |
| 2 | Eli Lilly and Company | 10 | 3 | 0 |
| 3 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Celgene Corporation | 6 | 1 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Topfond Pharmaceutical Co., Ltd. | 5 | 5 | 0 |
| 9 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Karuna Therapeutics Inc. | 5 | 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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500174 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500173 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500172 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500171 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500170 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500169 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/10Generic · Class 3 | Trimebutine Maleate TabletsCYHS2502462 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2025/07/10Generic · Class 3 | Trimebutine Maleate TabletsCYHS2502461 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2025/07/10Generic · Class 3 | Terlipressin Acetate InjectionCYHS2502457 | Wuhan Ren Fu Pharma Co., Ltd. romanized |
| 2025/07/10Generic · Class 3 | 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English nameCYHS2502456 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/07/10Generic · Class 3 | Esflurbiprofen PatchesCYHL2500125 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2025/07/10New drug · Class 3.1 | 半夏白术天麻颗粒 · No verified English nameCXZS2500028 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2025/07/10New drug · Class 3.1 | 真武颗粒 · No verified English nameCXZS2500027 | Wuhan Kang Le Pharma Co., Ltd. romanized |
| 2025/07/10New drug · Class 1 | DCTY0801注射液 · No verified English nameCXSL2500568 | Beijing Ding Cheng Tai Yuan Bio Technology Co., Ltd. romanized |
| 2025/07/10New drug · Class 1 | BGM0504片 · No verified English nameCXHL2500681 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/07/10New drug · Class 1 | BGM0504片 · No verified English nameCXHL2500680 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/07/10New drug · Class 1 | BGM0504片 · No verified English nameCXHL2500679 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/07/10New drug · Class 2.2 | EP-0206SI · No verified English nameCXHL2500670 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2025/07/10New drug · Class 2.2 | EP-0206SI · No verified English nameCXHL2500669 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2025/07/10New drug · Class 1 | SGB-3383注射液 · No verified English nameCXHL2500667 | Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500168 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500167 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500166 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500165 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500164 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Import · Class 1 | Mezigdomide胶囊 · No verified English nameJXHL2500163 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2502453 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Pregabalin Oral SolutionCYHS2502452 | Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | Loxoprofen sodium hydrate gelCYHS2502451 | Shanghai Yan An Pharmaceuticals Yang Pu Co., Ltd. romanized; Shanghai Yan An Pharma (Hubei) Co., Ltd. romanized |
| 2025/07/09Generic · Class 3 | 硝酸咪康唑乳膏 · No verified English nameCYHS2502449 | Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized |
115 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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