YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 287 drug applications between 11 April 2023 and 17 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 40 drug names.
2023/04/11 – 2023/04/17
- New acceptances this week
- 287
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
287filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 51 |
| New drug | 40 |
| Import | 18 |
| Import re-registration | 15 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 212 |
| TCM | 37 |
| Therapeutic biologic | 34 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
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
40 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 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 4 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 5 | 咪达唑仑口服溶液 · No verified English name | 2 | 1 | 0 |
| 6 | Nicorandil for Injection | 2 | 1 | 1 |
| 7 | Bupivacaine Hydrochloride Injection | 2 | 1 | 4 |
| 8 | 盐酸特比萘芬喷雾剂 · No verified English name | 2 | 1 | 7 |
| 9 | Lurasidone Hydrochloride Tablets | 2 | 1 | 2 |
| 10 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized | 36 | 31 | 0 |
| 2 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | 7 | 7 | 1 |
| 4 | McNeil Sweden AB | 6 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 5 | 2 | 0 |
| 6 | Eli Lilly and Company | 5 | 1 | 0 |
| 7 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Henan Lan Tian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 10 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 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
78 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/04/17Generic · Class 3 | Nicergoline TabletsCYHS2301063 | Beijing Foyou Pharma CO.,LTD |
| 2023/04/17New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2300009 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | BAT1308注射液 · No verified English nameCXSL2300263 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | HBW-3220胶囊 · No verified English nameCXHL2300382 | Chengdu Hai Bo Wei Pharma Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | 注射用MT1002 · No verified English nameCXHL2300381 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | 注射用MT1002 · No verified English nameCXHL2300380 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | WD-890片 · No verified English nameCXHL2300379 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | WD-890片 · No verified English nameCXHL2300378 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | WD-890片 · No verified English nameCXHL2300377 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | WD-890片 · No verified English nameCXHL2300376 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/17New drug · Class 1 | CPU-118片 · No verified English nameCXHL2300375 | Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/15Import · Class 1 | Monalizumab 注射液 · No verified English nameJXSL2300068 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/15Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2301060 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/04/15Generic · Class 3 | Diprophylline InjectionCYHS2301059 | Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2023/04/15Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301056 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/04/15New drug · Class 2.2 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2300262 | Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized |
| 2023/04/15New drug · Class 1 | RC198注射液 · No verified English nameCXSL2300261 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/04/15New drug · Class 1 | HS-10365胶囊 · No verified English nameCXHL2300374 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/15New drug · Class 1 | HEC53856片 · No verified English nameCXHL2300373 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/04/15New drug · Class 1 | HEC53856片 · No verified English nameCXHL2300372 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/04/14Import · Class 1 | LY3437943注射液 · No verified English nameJXHL2300084 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液 · No verified English nameJXHL2300083 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液 · No verified English nameJXHL2300082 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液 · No verified English nameJXHL2300081 | Eli Lilly and Company |
| 2023/04/14Import · Class 1 | LY3437943注射液 · No verified English nameJXHL2300080 | Eli Lilly and Company |
| 2023/04/14Generic · Class 3 | Isoniazid InjectionCYHS2301054 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized |
| 2023/04/14Generic · Class 3 | Entecavir oral solutionCYHS2301053 | Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
48 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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