YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 404 drug applications between 11 April 2026 and 17 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 49 drug names.
2026/04/11 – 2026/04/17
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 101
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
404filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 218 |
| New drug | 68 |
| Generic | 67 |
| Import | 28 |
| Unspecified | 12 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 128 |
| Therapeutic biologic | 70 |
| Biologic | 9 |
| Prophylactic biologic | 1 |
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
49 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 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 4 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 5 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 2 | 22 |
| 6 | Levetiracetam in Sodium Chloride Injection | 2 | 1 | 2 |
| 7 | Imipenem and Cilastatin Sodium for Injection | 2 | 1 | 6 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 10 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
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
254 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 7 | 4 | 0 |
| 2 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Novo Nordisk A/S | 6 | 1 | 0 |
| 4 | Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 4 | 0 |
| 8 | Hunan Guo Hua Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Xian Bo Ai Pharmaceutical 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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液 · No verified English nameJXSS2600039 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液 · No verified English nameJXSS2600038 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/04/17Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600116 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/04/17Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600115 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/04/17Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2600887 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/04/17Generic · Class 3 | Bepotastine Besilate Orally Disintegrating TabletsCYHS2600885 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2026/04/17Generic · Class 3 | Perospirone Hydrochloride TabletsCYHS2600884 | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2026/04/17Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600882 | Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2026/04/17Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600881 | Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2600426 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600425 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 3.2 | ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2600424 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized |
| 2026/04/17New drug · Class 2.2 | 伊匹木单抗N01注射液 · No verified English nameCXSL2600423 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2600422 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | BTL-203注射液 · No verified English nameCXSL2600421 | Ben Dao Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | DN002注射用冻干粉针剂 · No verified English nameCXSL2600420 | Suzhou Di Xin Chen Ke Bio Technology Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2600419 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2600418 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2600417 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2600416 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.4 | BJ044注射液 · No verified English nameCXSL2600415 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | 注射用HDM2017 · No verified English nameCXSL2600414 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | QY-iHEP02注射液 · No verified English nameCXSL2600413 | Beijing Tian You Qi Yuan Bio Technology Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | 注射用CAN016 · No verified English nameCXSL2600412 | Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | HS-10502片 · No verified English nameCXHL2600459 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/17New drug · Class 1 | HS-10502片 · No verified English nameCXHL2600458 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.4 | 注射用HRS5580 · No verified English nameCXHL2600457 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/04/17New drug · Class 2.4 | HY21006胶囊 · No verified English nameCXHL2600455 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2026/04/16Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSS2600037 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2026/04/16Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSS2600036 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
95 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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