YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 425 drug applications between 31 August 2026 and 6 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 44 drug names.
2026/08/31 – 2026/09/06
- New acceptances this week
- 425
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 320
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
425filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 238 |
| New drug | 76 |
| Generic | 56 |
| Import | 40 |
| Import re-registration | 10 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 146 |
| Therapeutic biologic | 80 |
| Prophylactic biologic | 4 |
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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rotigotine Patches | 3 | 1 | 7 |
| 2 | Lactulose Oral Solution | 2 | 1 | 34 |
| 3 | 二硫化硒洗剂 · No verified English name | 2 | 1 | 14 |
| 4 | Eplerenone Tablets | 2 | 1 | 4 |
| 5 | Empagliflozin Tablets | 2 | 1 | 18 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 8 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Ferric Carboxymaltose Injection | 2 | 1 | 10 |
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
244 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Inc. | 8 | 1 | 0 |
| 2 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Novartis Pharma AG | 7 | 4 | 0 |
| 4 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 5 | Pfizer Inc. | 6 | 4 | 0 |
| 6 | AstraZeneca AB | 6 | 2 | 0 |
| 7 | Changchun Jin Sai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 8 | Beijing Kang Di Ni Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/04Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600239 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/09/04Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600238 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/09/04Import · Class 1 | FUB523注射液 · No verified English nameJXSL2600237 | Novartis Pharma AG |
| 2026/09/04Import · Class 1 | Giredestrant胶囊 · No verified English nameJXHL2600397 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/04Import · Class 2.4 | Zavegepant鼻喷雾剂 · No verified English nameJXHL2600396 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/04Import · Class 1 | MK-1084片 · No verified English nameJXHL2600395 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/09/04Import · Class 1 | MK-1084片 · No verified English nameJXHL2600394 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/09/04Generic · Class 3 | Simethicone Chewable TabletsCYHS2602208 | Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2026/09/04Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2602206 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2026/09/04Generic · Class 3 | Dexmethylphenidate Hydrochloride TabletsCYHL2600095 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2026/09/04New drug · Class 3.2 | 注射用人促甲状腺素β · No verified English nameCXSS2600145 | Name not romanized |
| 2026/09/04New drug · Class 1 | 注射用NCB005 · No verified English nameCXSL2600962 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/04New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600961 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/04New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2600960 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | 注射用 B024 · No verified English nameCXSL2600959 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/04New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2601079 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | BW-20507-2注射液 · No verified English nameCXHL2601078 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | KC1101片 · No verified English nameCXHL2601077 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | KC1101片 · No verified English nameCXHL2601076 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | KC1101片 · No verified English nameCXHL2601075 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | ZN-F-6418胶囊 · No verified English nameCXHL2601074 | Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | ZN-F-6418胶囊 · No verified English nameCXHL2601073 | Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | IN10018片 · No verified English nameCXHL2601072 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2026/09/04New drug · Class 1 | IN10018片 · No verified English nameCXHL2601071 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2026/09/03Import · Class 1 | 伐米奇拜单抗注射液 · No verified English nameJXSS2600089 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/09/03Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2600088 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2026/09/03Import · Class 1 | Budoprutug注射液 · No verified English nameJXSL2600236 | Climb Bio Inc.; Beijing Mabworks Biotech Company Limited |
| 2026/09/03Import · Class 1 | EDK060 · No verified English nameJXHL2600393 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/03Import · Class 1 | verducatib 片 · No verified English nameJXHL2600392 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/09/03Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2602204 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
103 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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