YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 297 drug applications between 12 April 2023 and 18 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 46 drug names.
2023/04/12 – 2023/04/18
- New acceptances this week
- 297
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 1
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
297filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 150 |
| Generic | 56 |
| New drug | 52 |
| Import | 20 |
| Import re-registration | 11 |
| Unspecified | 7 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 56 |
| Therapeutic biologic | 33 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| Drug-device combination | 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diprophylline Injection | 3 | 3 | 7 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 3 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 4 | 咪达唑仑口服溶液 · No verified English name | 2 | 1 | 0 |
| 5 | Lacosamide Injection | 2 | 1 | 0 |
| 6 | Nicorandil for Injection | 2 | 1 | 1 |
| 7 | Bupivacaine Hydrochloride Injection | 2 | 1 | 4 |
| 8 | Lurasidone Hydrochloride Tablets | 2 | 1 | 2 |
| 9 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 10 | Sodium Valproate Sustained-release Tablets(I) | 1 | 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
169 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 23 | 23 | 0 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Sichuan Kelun Pharmaceutical Co., Ltd. | 6 | 4 | 2 |
| 4 | Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 5 | McNeil Sweden AB | 6 | 1 | 0 |
| 6 | Janssen Research & Development LLC | 5 | 2 | 0 |
| 7 | Eli Lilly and Company | 5 | 1 | 0 |
| 8 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Henan Lan Tian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 3 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/18Import · Class 2.3 | 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300035 | Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd. |
| 2023/04/18Import · Class 2.3 | 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300034 | Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300087 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300086 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300085 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Generic · Class 3 | Mepivacaine Hydrochloride InjectionCYHS2301073 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/04/18Generic · Class 3 | Baclofen Oral SolutionCYHS2301070 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/04/18Generic · Class 3 | Diquafosol Sodium Eye DropsCYHL2300055 | Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2023/04/18New drug · Class 1.1 | 养阴舒肝颗粒 · No verified English nameCXZL2300027 | Guangzhou Pharmaceuticals Research Zong Yuan Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300270 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300269 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300268 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300267 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | KN056注射液 · No verified English nameCXSL2300266 | Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized |
| 2023/04/18New drug · Class 3.3 | 重组抗CTLA-4全人单克隆抗体注射液 · No verified English nameCXSL2300265 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2300264 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.2 | LJ01003 · No verified English nameCXHS2300046 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.2 | LJ01003 · No verified English nameCXHS2300045 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.4 | Fruquintinib CapsulesCXHS2300044 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.4 | Fruquintinib CapsulesCXHS2300043 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2300389 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2300388 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | TQ05105片 · No verified English nameCXHL2300387 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/04/18New drug · Class 1 | TQB3617胶囊 · No verified English nameCXHL2300386 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/04/18New drug · Class 1 | TQB3617胶囊 · No verified English nameCXHL2300385 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/04/18New drug · Class 1 | CS23546片 · No verified English nameCXHL2300384 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CS23546片 · No verified English nameCXHL2300383 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2023/04/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2301068 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2023/04/17Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301066 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/04/17Generic · Class 3 | Proparacaine Hydrochloride Eye DropsCYHS2301065 | Hefei Li Fang Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized |
65 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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