YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 400 drug applications between 7 April 2026 and 13 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.
2026/04/07 – 2026/04/13
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 115
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
400filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 213 |
| Generic | 82 |
| New drug | 61 |
| Import | 28 |
| Import re-registration | 10 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 116 |
| Therapeutic biologic | 64 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平萨米多芬片 · No verified English name | 4 | 1 | 0 |
| 2 | Ibuprofen Suspension | 3 | 2 | 14 |
| 3 | Diclofenac Diethylamine Emulgel | 3 | 1 | 20 |
| 4 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 5 | Topiramate Extended-release Capsules | 3 | 1 | 0 |
| 6 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 7 | 盐酸毛果芸香碱滴眼液 · No verified English name | 2 | 2 | 5 |
| 8 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Levetiracetam in Sodium Chloride Injection | 2 | 1 | 2 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Wan Sui Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Novo Nordisk A/S | 10 | 3 | 0 |
| 3 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Merck Sharp & Dohme B.V. | 6 | 2 | 0 |
| 5 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
123 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/13Import · Class 2.4 | 塞伐艾替尼片 · No verified English nameJXHS2600038 | Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/04/13Import · Class 2.4 | Trientine Hydrochloride TabletsJXHL2600111 | Orphalan SA; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2026/04/13Import · Class 2.4 | 英克司兰钠注射液 · No verified English nameJXHL2600110 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/04/13Generic · Class 3 | Amifampridine phosphate tabletsCYHS2600850 | Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | Furosemide Oral SolutionCYHS2600849 | Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/04/13Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2600848 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2600053 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2600052 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2600051 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2600050 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2600049 | Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2600048 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2600047 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/04/13Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2600046 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/04/13New drug · Class 1.1 | 天精泽兰颗粒 · No verified English nameCXZL2600035 | Lei Yun Shang Pharma Group Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized |
| 2026/04/13New drug · Class 2.2 | 注射用泽尼达妥单抗 · No verified English nameCXSS2600064 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | STX11101注射液 · No verified English nameCXSL2600403 | Shanghai Si De Ke Suo Bio Technology Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | 注射用HWS113 · No verified English nameCXSL2600402 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | 注射用HDM2005 · No verified English nameCXSL2600401 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | HRS-8797片 · No verified English nameCXHL2600434 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | HRS-8797片 · No verified English nameCXHL2600433 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/13New drug · Class 1 | HRS-8797片 · No verified English nameCXHL2600432 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/13New drug · Class 2.3 | 海博麦布氨氯地平阿托伐他汀钙片 · No verified English nameCXHL2600431 | Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600097 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600096 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600095 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600094 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600093 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600092 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Generic · Class 3 | 艾地骨化醇片 · No verified English nameCYHS2600842 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
93 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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