YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 311 drug applications between 17 April 2024 and 23 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.
2024/04/17 – 2024/04/23
- New acceptances this week
- 311
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 2
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
311filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 131 |
| Generic | 95 |
| New drug | 59 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| TCM | 52 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 5 |
| 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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Solution For Inhalation | 4 | 2 | 10 |
| 2 | 地氯雷他定口服溶液 · No verified English name | 3 | 2 | 26 |
| 3 | 二甲硅油乳剂 · No verified English name | 3 | 1 | 14 |
| 4 | Palbociclib Capsules | 3 | 1 | 0 |
| 5 | Pamidronate Disodium Injection | 3 | 1 | 2 |
| 6 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 7 | Aripiprazole Oral Solution | 3 | 1 | 4 |
| 8 | Pranoprofen Eye Drops | 2 | 2 | 7 |
| 9 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chen Huan Pharmaceuticals Group Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 9 | 3 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 4 | Hua Jin (Chongqing) Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 5 | 2 | 3 |
| 7 | Qinghai Jiu Mei Zang Yao Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 9 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/23Import · Class 1 | 注射用ASP5354 · No verified English nameJXHL2400095 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/04/23Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2401222 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2401221 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2401220 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2401218 | Shanghai Feng Lin Bio Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Potassium Phosphates InjectionCYHS2401217 | Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/04/23Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2401215 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 德昔度司他片 · No verified English nameCYHS2401213 | Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2401212 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2401211 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 眼用丝裂霉素溶液用粉末 · No verified English nameCYHS2401210 | Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2401209 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/04/23Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2401208 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Acetylcysteine InjectionCYHS2401207 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2401206 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2024/04/23Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2401202 | Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2024/04/23New drug · Class 1 | 人羊膜间充质干细胞注射液 · No verified English nameCXSL2400258 | Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized |
| 2024/04/23New drug · Class 1.2 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2400257 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/04/23New drug · Class 1 | MRG006A · No verified English nameCXSL2400256 | Le Pu Bio Technology Co., Ltd. romanized |
| 2024/04/23New drug · Class 1 | BC008-1A注射液 · No verified English nameCXSL2400255 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | 氟唑帕利胶囊 · No verified English nameCXHS2400032 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | Apatinib Mesylate TabletsCXHS2400031 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | Apatinib Mesylate TabletsCXHS2400030 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHL2400411 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400410 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400409 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/23New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400408 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/04/22Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401201 | Guangdong Ding Xin Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/04/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2401200 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanized |
| 2024/04/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2401199 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanized |
84 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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