YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 333 drug applications between 7 April 2023 and 13 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 51 drug names.
2023/04/07 – 2023/04/13
- New acceptances this week
- 333
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 0
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
333filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 192 |
| Generic | 68 |
| New drug | 39 |
| Import re-registration | 14 |
| Import | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| Therapeutic biologic | 47 |
| TCM | 29 |
| 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
51 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 | Everolimus Tablets | 2 | 1 | 2 |
| 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 | Ibuprofen Injection | 2 | 1 | 8 |
| 7 | Torsemide Injection | 2 | 1 | 1 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | Phenylephrine Hydrochloride Injection | 2 | 1 | 5 |
| 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
177 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 | Janssen Research & Development LLC | 7 | 4 | 0 |
| 3 | Luye Pharma Limited | 7 | 1 | 0 |
| 4 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | McNeil Sweden AB | 6 | 1 | 0 |
| 6 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Organon Pharma (UK) Limited | 5 | 1 | 0 |
| 8 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 9 | Beijing Han Mei Medicines Co., Ltd. romanized | 4 | 4 | 3 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/04/13Generic · Class 3 | Diclofenac Sodium InjectionCYHS2301043 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2023/04/13Generic · Class 3 | Diprophylline InjectionCYHS2301042 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2023/04/13Generic · Class 3 | Diprophylline InjectionCYHS2301041 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/04/13Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHL2300054 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2023/04/13Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHL2300053 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2023/04/13New drug · Class 1 | HH-012注射液 · No verified English nameCXSL2300256 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/04/13New drug · Class 1 | 注射用JYB1907 · No verified English nameCXSL2300255 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized |
| 2023/04/13New drug · Class 1 | SPH4336片 · No verified English nameCXHL2300364 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/04/12Import · Class 2.2 | Isatuximab注射液 · No verified English nameJXSL2300067 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/04/12Import · Class 2.2 | Teclistamab 注射液 · No verified English nameJXSL2300066 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/04/12Import · Class 2.2 | Teclistamab 注射液 · No verified English nameJXSL2300065 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/04/12Generic · Class 3 | 咪达唑仑口服溶液 · No verified English nameCYHS2301040 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | 咪达唑仑口服溶液 · No verified English nameCYHS2301039 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2301038 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | Nicorandil for InjectionCYHS2301036 | Tian Da Pharma (Yunnan) Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | Nicorandil for InjectionCYHS2301035 | Tian Da Pharma (Yunnan) Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2301027 | Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2023/04/12Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2301026 | Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2023/04/12New drug · Class 1 | SHR-1703注射液 · No verified English nameCXSL2300253 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/12New drug · Class 3.2 | ACYW135 群脑膜炎球菌多糖结合疫苗(CRM197 载体) · No verified English nameCXSL2300252 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2023/04/12New drug · Class 1 | 注射用ZB001 · No verified English nameCXSL2300251 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2023/04/12New drug · Class 1 | IBI346 · No verified English nameCXSL2300250 | Xin Da Xi Bao Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/04/12New drug · Class 2.4 | Neratinib Maleate TabletsCXHL2300363 | Fu Kang (Shanghai) Health Technology Co., Ltd. romanized |
| 2023/04/12New drug · Class 1 | AHB-137注射液 · No verified English nameCXHL2300362 | Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized |
| 2023/04/11Import · Class 2.2 | 法瑞西单抗注射液 · No verified English nameJXSS2300030 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
59 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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