YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 381 drug applications between 19 September 2024 and 25 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 83 drug names.
2024/09/19 – 2024/09/25
- New acceptances this week
- 381
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 6
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
381filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 122 |
| New drug | 59 |
| Import | 33 |
| Unspecified | 22 |
| Import re-registration | 12 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 64 |
| Therapeutic biologic | 46 |
| Biologic | 20 |
| 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
83 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fentanyl Citrate Buccal Tablets | 6 | 1 | 0 |
| 2 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 6 | 1 | 14 |
| 3 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 4 | Polymyxin B sulfate for Injection | 3 | 3 | 6 |
| 5 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 6 | Carbamazepine Sustained-Release Tablets(II) | 3 | 1 | 0 |
| 7 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 8 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 9 | Amoxicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 7 |
| 10 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 12 | 3 | 0 |
| 2 | Amgen Inc. | 9 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 2 | 9 |
| 4 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Janssen-Cilag International NV | 6 | 2 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Baxalta Manufacturing Sàrl | 6 | 1 | 0 |
| 8 | Shandong Jing Hui Bio Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 9 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | AbbVie Inc. | 5 | 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
141 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/25Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400078 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/09/25Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400077 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/09/25Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400076 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/09/25Import · Class 2.1 | 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400075 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/09/25Import · Class 1 | ABBV-706注射用冻干粉 · No verified English nameJXSL2400179 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/09/25Import · Class 1 | MEDI5752 · No verified English nameJXSL2400178 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/25Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400177 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/25Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400176 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/25Import · Class 1 | DS-7300a · No verified English nameJXSL2400175 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD |
| 2024/09/25Import · Class 1 | AZD2936 · No verified English nameJXSL2400174 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/25Import · Class 1 | AZD2936 · No verified English nameJXSL2400173 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/25Import · Class 2.4 | Sotorasib 片 · No verified English nameJXHL2400234 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400233 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400232 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400231 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400230 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2400229 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400228 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400227 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | GDC-0077 · No verified English nameJXHL2400226 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/09/25Import · Class 1 | GDC-0077 · No verified English nameJXHL2400225 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400224 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Import · Class 1 | AMG 193 · No verified English nameJXHL2400223 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2024/09/25Generic · Class 3 | Risedronate Sodium TabletsCYHS2403229 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2403223 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2403218 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2403217 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2403216 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | Amikacin Sulfate injectionCYHS2403213 | Kang Pu Pharma Co., Ltd. romanized |
| 2024/09/25Generic · Class 3 | Cycloserine CapsulesCYHS2403212 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
111 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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