YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 376 drug applications between 10 April 2023 and 16 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.
2023/04/10 – 2023/04/16
- New acceptances this week
- 376
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
376filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 212 |
| Generic | 75 |
| New drug | 46 |
| Import | 18 |
| Import re-registration | 15 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 282 |
| Therapeutic biologic | 49 |
| TCM | 39 |
| Prophylactic biologic | 4 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Diprophylline Injection | 3 | 3 | 7 |
| 3 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 4 | Everolimus Tablets | 2 | 1 | 2 |
| 5 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 6 | 咪达唑仑口服溶液 · No verified English name | 2 | 1 | 0 |
| 7 | Ibuprofen Injection | 2 | 1 | 8 |
| 8 | Torsemide Injection | 2 | 1 | 1 |
| 9 | Nicorandil for Injection | 2 | 1 | 1 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
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
196 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized | 41 | 36 | 0 |
| 2 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Janssen Research & Development LLC | 7 | 4 | 0 |
| 4 | Luye Pharma Limited | 7 | 1 | 0 |
| 5 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | McNeil Sweden AB | 6 | 1 | 0 |
| 8 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Eli Lilly and Company | 5 | 1 | 0 |
| 10 | Organon Pharma (UK) Limited | 5 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/04/14New drug · Class 1 | 注射用培重组人凝血因子IX-Fc融合蛋白 · No verified English nameCXSL2300260 | Zhengzhou Cheng Si Bio Technology Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | 注射用培重组人凝血因子IX-Fc融合蛋白 · No verified English nameCXSL2300259 | Zhengzhou Cheng Si Bio Technology Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2300371 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2300370 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2300369 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2300368 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2300367 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | TollB-001片 · No verified English nameCXHL2300366 | Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized |
| 2023/04/14New drug · Class 1 | TollB-001片 · No verified English nameCXHL2300365 | Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized |
| 2023/04/13Import · Class 3.1 | 地舒单抗注射液 · No verified English nameJXSS2300031 | Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2023/04/13Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300079 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/04/13Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300078 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/04/13Import · Class 2.2 | ASKC200搽剂 · No verified English nameJXHL2300077 | Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD |
| 2023/04/13Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHS2301045 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
71 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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