YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 393 drug applications between 28 November 2025 and 4 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 66 drug names.
2025/11/28 – 2025/12/04
- New acceptances this week
- 393
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 100
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
393filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 210 |
| Generic | 83 |
| New drug | 53 |
| Import | 34 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 109 |
| Therapeutic biologic | 54 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Crisaborole Ointment | 2 | 2 | 26 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 3 | Mupirocin Ointment | 2 | 2 | 30 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | 奥洛他定莫米松鼻喷雾剂 · No verified English name | 2 | 1 | 1 |
| 6 | Levonorgestrel Tablets | 2 | 1 | 5 |
| 7 | Teneligliptin Hydrobromide Hydrate Tablets | 2 | 1 | 10 |
| 8 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
| 9 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
| 10 | Clopidogrel Hydrogen Sulphate Tablets | 2 | 1 | 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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 19 | 19 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | AstraZeneca AB | 6 | 5 | 0 |
| 5 | Amgen Inc. | 6 | 2 | 0 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Xian Le Xi Medical Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Beijing Sai Er Bio Pharma Co., Ltd. romanized | 5 | 4 | 5 |
| 9 | Merck Sharp & Dohme B.V. | 5 | 3 | 0 |
| 10 | Zhong Shan Kang Fang Biopharmaceuticals 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/04Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2500148 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/12/04Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2500236 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/12/04Import · Class 1 | RO7790121注射液 · No verified English nameJXSL2500235 | F. Hoffmann-La Roche Ltd. |
| 2025/12/04Import · Class 1 | AZD2936 · No verified English nameJXSL2500234 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/04Import · Class 1 | AZD8205 · No verified English nameJXSL2500233 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/04Import · Class 1 | Cevostamab · No verified English nameJXSL2500232 | Genentech Inc.; Roche(China)Holding Ltd. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500387 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500386 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500385 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500384 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500383 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500382 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500381 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500380 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | AZD9574 · No verified English nameJXHL2500379 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/04Import · Class 1 | AZD9574 · No verified English nameJXHL2500378 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500377 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500376 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500375 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | Eloralintide注射液 · No verified English nameJXHL2500374 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2025/12/04Import · Class 1 | RO7435846片 · No verified English nameJXHL2500373 | F. Hoffmann-La Roche Ltd |
| 2025/12/04Import · Class 1 | RO7435846片 · No verified English nameJXHL2500372 | F. Hoffmann-La Roche Ltd |
| 2025/12/04Import · Class 1 | RO7435846片 · No verified English nameJXHL2500371 | F. Hoffmann-La Roche Ltd |
| 2025/12/04Generic · Class 3 | Indocyaninegreen for InjectionCYHS2504164 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2025/12/04Generic · Class 3 | 乳酸维持液含葡萄糖10% · No verified English nameCYHS2504161 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/12/04Generic · Class 3 | Esflurbiprofen PatchesCYHL2500213 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/12/04New drug · Class 1 | HB0056注射液 · No verified English nameCXSL2501039 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/04New drug · Class 1 | 注射用SSS50 · No verified English nameCXSL2501038 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/12/04New drug · Class 1 | 地尼法司他片 · No verified English nameCXHS2500147 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized; Ge Li Pharma (Zhejiang) Co., Ltd. romanized |
| 2025/12/03Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2504156 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
78 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.