YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 377 drug applications between 16 April 2026 and 22 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 44 drug names.
2026/04/16 – 2026/04/22
- New acceptances this week
- 377
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 97
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
377filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 208 |
| New drug | 73 |
| Generic | 58 |
| Import | 15 |
| Import re-registration | 12 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 135 |
| Therapeutic biologic | 48 |
| Biologic | 10 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 2 | 12 |
| 2 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 3 | Teicoplanin for Injection | 2 | 2 | 6 |
| 4 | 头孢丙烯干混悬剂 · No verified English name | 2 | 1 | 2 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 6 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 7 | Imipenem and Cilastatin Sodium for Injection | 2 | 1 | 6 |
| 8 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 9 | 盐酸氢吗啡酮片 · No verified English name | 2 | 1 | 0 |
| 10 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
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
247 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Xinjiang Wei Wu Er Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Fuzhou Min Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Yunnan Bai Yao Group Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF) | 4 | 2 | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/22Import · Class 1 | AZD2265 · No verified English nameJXHL2600118 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/04/22Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600923 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized |
| 2026/04/22Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2600921 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2026/04/22Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2600920 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2026/04/22Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2600919 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2026/04/22Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2600916 | Beijing Hai Jing Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 注射用ZHB130 · No verified English nameCXSL2600436 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | RGL-185注射液 · No verified English nameCXSL2600435 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 注射用IPN60300 · No verified English nameCXSL2600434 | Yi Pu Sheng (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 注射用ESG406 · No verified English nameCXSL2600433 | Shanghai Shi Jian Bio Technology Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 注射用IMM2510S · No verified English nameCXSL2600432 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 注射用SKB315 · No verified English nameCXSL2600431 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600430 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600429 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | 布地奈德福莫特罗吸入粉雾剂(IV)胶囊型 · No verified English nameCXHS2600059 | Hangzhou Chang Xi Pharmaceutical Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | 醋酸索乐匹尼布片 · No verified English nameCXHS2600058 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600057 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600056 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600055 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2600054 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | GT818胶囊 · No verified English nameCXHL2600483 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | GT818胶囊 · No verified English nameCXHL2600482 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | BN114723 · No verified English nameCXHL2600481 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | BN114723 · No verified English nameCXHL2600480 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.2 | BN114723 · No verified English nameCXHL2600479 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.4 | Neratinib Maleate TabletsCXHL2600478 | Fu Kang Bio Technology (Shanghai) Co., Ltd. romanized; Fu Kang (Hubei Sheng) Bio Technology Kai Fa Co., Ltd. romanized |
| 2026/04/22New drug · Class 2.4 | 无水乙醇注射液 · No verified English nameCXHL2600477 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600476 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600475 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/04/22New drug · Class 1 | IN10018片 · No verified English nameCXHL2600474 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
79 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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