YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 423 drug applications between 1 September 2026 and 7 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 53 drug names.
2026/09/01 – 2026/09/07
- New acceptances this week
- 423
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 334
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
423filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| New drug | 79 |
| Generic | 68 |
| Import | 32 |
| Import re-registration | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 139 |
| Therapeutic biologic | 75 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 3 | 2 | 30 |
| 2 | Rotigotine Patches | 3 | 1 | 7 |
| 3 | Dexketoprofen Trometamol Injection | 2 | 2 | 6 |
| 4 | Lactulose Oral Solution | 2 | 1 | 34 |
| 5 | Dotinurad Tablets | 2 | 1 | 55 |
| 6 | Empagliflozin Tablets | 2 | 1 | 18 |
| 7 | Ticagrelor Tablets | 2 | 1 | 10 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 9 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 10 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
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
257 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 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Novartis Pharma AG | 6 | 4 | 0 |
| 5 | Beijing Kang Di Ni Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | Pfizer Inc. | 5 | 3 | 0 |
| 9 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Changchun Jin Sai Pharma Co., Ltd. romanized | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/07Import · Class 1 | DKB903注射用浓溶液 · No verified English nameJXSL2600240 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/07Generic · Class 3 | 复方葡萄糖/电解质颅脑手术冲洗液 · No verified English nameCYHS2602231 | Wu Hu Dao Run Pharma Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | Entecavir oral solutionCYHS2602228 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2602227 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | Pimavanserin Tartrate CapsulesCYHS2602224 | Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2602222 | Hefei He Yuan Pharma Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2602215 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2026/09/07Generic · Class 3 | 酒石酸匹莫范色林片 · No verified English nameCYHS2602212 | Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized |
| 2026/09/07Generic · Class 3 | 黄体酮注射液(Ⅱ) · No verified English nameCYHS2602210 | Wuhan Jiu Long Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/09/07New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600147 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2026/09/07New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600146 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2026/09/07New drug · Class 1 | JH035注射液 · No verified English nameCXSL2600966 | Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized |
| 2026/09/07New drug · Class 2.2 | 吸附无细胞百(五组分)白破联合疫苗 · No verified English nameCXSL2600965 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2026/09/07New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2600964 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/09/07New drug · Class 1 | SYS6085注射液 · No verified English nameCXSL2600963 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
| 2026/09/07New drug · Class 1 | 奥莱泊肽注射液 · No verified English nameCXHS2600126 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Name not romanized |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片 · No verified English nameCXHL2601084 | Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片 · No verified English nameCXHL2601083 | Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/07New drug · Class 2.2 | 司美格鲁肽微针贴片 · No verified English nameCXHL2601082 | Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/07New drug · Class 1 | HRS-4518舌下片 · No verified English nameCXHL2601081 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/07New drug · Class 1 | HRS-4518舌下片 · No verified English nameCXHL2601080 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 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 |
101 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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