YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 212 drug applications between 3 May 2024 and 9 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.
2024/05/03 – 2024/05/09
- New acceptances this week
- 212
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
212filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 94 |
| Generic | 60 |
| New drug | 31 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 137 |
| Therapeutic biologic | 37 |
| TCM | 36 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Telmisartan Tablets | 3 | 1 | 4 |
| 2 | Deutetrabenazine Tablets | 3 | 1 | 0 |
| 3 | Lactulose Oral Solution | 2 | 1 | 34 |
| 4 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 5 | Perampanel Tablets | 2 | 1 | 2 |
| 6 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 7 | 头孢地尼干混悬剂 · No verified English name | 2 | 1 | 2 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Cytarabine for Injection | 2 | 1 | 2 |
| 10 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
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
140 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 2 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 6 | 2 | 3 |
| 3 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Hubei Di Liu Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | AstraZeneca AB | 4 | 3 | 0 |
| 7 | Takeda Pharmaceuticals International AG Ireland Branch | 4 | 2 | 0 |
| 8 | Topfond Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 9 | Ma Ying Long Pharma Group Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 3 | 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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/09Import · Class 1 | LOXO-435片 · No verified English nameJXHL2400104 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/05/09Import · Class 1 | LOXO-435片 · No verified English nameJXHL2400103 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/05/09Import · Class 1 | LOXO-435片 · No verified English nameJXHL2400102 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/05/09Import · Class 2.4 | Capivasertib片 · No verified English nameJXHL2400101 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/05/09Import · Class 2.4 | Capivasertib片 · No verified English nameJXHL2400100 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/05/09Generic · Class 3 | Etoposide InjectionCYHS2401384 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2024/05/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2401383 | Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2024/05/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2401382 | Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2024/05/09Generic · Class 3 | Indocyaninegreen for InjectionCYHS2401375 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized |
| 2024/05/09Generic · Class 3 | Trimebutine Maleate TabletsCYHS2401370 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/05/09Generic · Class 3 | Potassium Aspartate And Magnesium Aspartate InjectionCYHS2401369 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/09New drug · Class 1.1 | 蒿平颗粒 · No verified English nameCXZL2400024 | Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized |
| 2024/05/09New drug · Class 3.3 | 乌司奴单抗注射液 · No verified English nameCXSS2400048 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/05/09New drug · Class 3.3 | 乌司奴单抗注射液(静脉输注) · No verified English nameCXSS2400047 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/05/09New drug · Class 3.3 | 乌司奴单抗注射液 · No verified English nameCXSS2400046 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | 注射用CB-002 · No verified English nameCXSL2400297 | Shanghai Mai Ke Si Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | LM-299注射液 · No verified English nameCXSL2400296 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/05/09New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2400295 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | KN069注射液 · No verified English nameCXSL2400294 | Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized |
| 2024/05/09New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2400293 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | 9MW2821 · No verified English nameCXSL2400292 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | 注射用BL-M14D1 · No verified English nameCXSL2400291 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 3.3 | 23价肺炎球菌多糖疫苗 · No verified English nameCXSL2400290 | Fu Xing An Te Jin (Chengdu) Biopharmaceutical Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2400439 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2400438 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | HP-001胶囊 · No verified English nameCXHL2400437 | Shanghai Chao Yang Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | HRN01胶囊 · No verified English nameCXHL2400436 | Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | HRN01胶囊 · No verified English nameCXHL2400435 | Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | LW347片 · No verified English nameCXHL2400434 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2024/05/09New drug · Class 1 | LW347片 · No verified English nameCXHL2400433 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
39 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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