YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 5 April 2026 and 11 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 51 drug names.
2026/04/05 – 2026/04/11
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 104
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
347filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 68 |
| New drug | 52 |
| Import | 25 |
| Import re-registration | 10 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 186 |
| TCM | 97 |
| Therapeutic biologic | 57 |
| 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ibuprofen Suspension | 3 | 2 | 14 |
| 2 | Diclofenac Diethylamine Emulgel | 3 | 1 | 20 |
| 3 | Topiramate Extended-release Capsules | 3 | 1 | 0 |
| 4 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 5 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Levetiracetam in Sodium Chloride Injection | 2 | 1 | 2 |
| 8 | Erythromycin Lactobionate for Injection | 2 | 1 | 13 |
| 9 | Dexmethylphenidate Hydrochloride Exended-release Capsules | 2 | 1 | 2 |
| 10 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
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
193 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 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 10 | Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized | 4 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/04/11Generic · Class 3 | 艾地骨化醇片 · No verified English nameCYHS2600841 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/04/11Generic · Class 3 | Acetylcysteine GranulesCYHS2600840 | Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized |
| 2026/04/11Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2600837 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/04/11Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2600836 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/04/11Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2600834 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2026/04/11Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2600833 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2026/04/11Generic · Class 3 | 东莨菪碱透皮贴片 · No verified English nameCYHL2600045 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2026/04/11New drug · Class 1 | HLX3902注射液 · No verified English nameCXSL2600400 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/11New drug · Class 1 | 注射用LY4175408 · No verified English nameCXSL2600399 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2026/04/11New drug · Class 2.2 | 注射用SIM0692 · No verified English nameCXSL2600398 | Shandong Xian Sheng Zai Ming Biopharmaceutical Co., Ltd. romanized |
| 2026/04/11New drug · Class 1 | 注射用KR25102 · No verified English nameCXHL2600430 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/04/10Import · Class 3.1 | 奥妥珠单抗注射液 · No verified English nameJXSS2600034 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/04/10Import · Class 2.3 | 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600098 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/04/10Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2600830 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2026/04/10Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600829 | Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/04/10Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2600044 | Shandong Hui Cheng Pharma Co., Ltd. romanized |
| 2026/04/10Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2600043 | Shandong Hui Cheng Pharma Co., Ltd. romanized |
| 2026/04/10New drug · Class 1 | SGT003注射液 · No verified English nameCXSL2600397 | Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/10New drug · Class 1 | YB1-X7注射液(静脉输注) · No verified English nameCXSL2600396 | Shao Xing Shan Wei Te Bio Technology Co., Ltd. romanized |
| 2026/04/10New drug · Class 2.2 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600395 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/10New drug · Class 2.2 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600394 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/10New drug · Class 2.2 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600393 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/10New drug · Class 2.2 | 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600392 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized |
70 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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