YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 422 drug applications between 27 July 2023 and 2 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 60 drug names.
2023/07/27 – 2023/08/02
- New acceptances this week
- 422
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
422filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 238 |
| Generic | 81 |
| New drug | 64 |
| Import | 25 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 85 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 1 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Topiroxostat Tablets | 4 | 2 | 0 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 3 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 4 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 5 | Palbociclib Tablets | 2 | 1 | 2 |
| 6 | Multiple Electrolytes Injection(Ⅱ) | 2 | 1 | 1 |
| 7 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 8 | Bendamustine Hydrochloride For Injection | 2 | 1 | 2 |
| 9 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 10 | Tapentadol Hydrochloride Extended Release Tablets | 2 | 1 | 0 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Qing Gong Pharma Group Co., Ltd. romanized | 29 | 29 | 0 |
| 2 | Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 3 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Liaoning Hua Rui Joint Pharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 6 | Bayer AG | 8 | 1 | 0 |
| 7 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 7 | 2 | 0 |
| 8 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 7 | 1 | 0 |
| 9 | Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 10 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. | 6 | 3 | 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 |
|---|---|---|
| 2023/08/02Import · Class 3.1 | Brolucizumab注射液 · No verified English nameJXSS2300068 | Novartis Europharm Ltd.; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd. |
| 2023/08/02Import · Class 3.1 | Brolucizumab注射液 · No verified English nameJXSS2300067 | Novartis Europharm Ltd.; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2023/08/02Import · Class 2.2 | DS-8201a · No verified English nameJXSL2300149 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/08/02Import · Class 2.4 | Ritlecitinib胶囊 · No verified English nameJXHL2300182 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/08/02Import · Class 2.4 | Ritlecitinib胶囊 · No verified English nameJXHL2300181 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/08/02Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302067 | Shenzhen Da Fu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/02Generic · Class 3 | Ebastine Oral SolutionCYHS2302066 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/08/02Generic · Class 3 | Minoxidil LinimentCYHS2302063 | Guangdong Quan Xin Quan Yi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/02Generic · Class 3 | Minoxidil LinimentCYHS2302062 | Guangdong Quan Xin Quan Yi Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/02Generic · Class 3 | Tapentadol Hydrochloride Extended Release TabletsCYHL2300096 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/08/02Generic · Class 3 | Tapentadol Hydrochloride Extended Release TabletsCYHL2300095 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 悬铃木花粉点刺液 · No verified English nameCXSS2300064 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 猫毛皮屑点刺液 · No verified English nameCXSS2300063 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 德国小蠊点刺液 · No verified English nameCXSS2300062 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 全人源抗破伤风毒素单克隆抗体A82/B86注射液组合制剂 · No verified English nameCXSL2300536 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2023/08/02New drug · Class 1 | 靶向CD19和CD22的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2300535 | Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.1 | 替雷利珠单抗注射液(皮下注射) · No verified English nameCXSL2300534 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | HB0017注射液 · No verified English nameCXSL2300533 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.4 | Roxadustat CapsulesCXHS2300068 | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.4 | Roxadustat CapsulesCXHS2300067 | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 磷酸安泰他韦胶囊 · No verified English nameCXHS2300066 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球 · No verified English nameCXHS2300065 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球 · No verified English nameCXHS2300064 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球 · No verified English nameCXHS2300063 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球 · No verified English nameCXHS2300062 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized; Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2300853 | Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2300852 | Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/02New drug · Class 1 | 盐酸钩吻素子片 · No verified English nameCXHL2300851 | Fujian Yi Ke University romanized |
| 2023/08/02New drug · Class 1 | 盐酸钩吻素子片 · No verified English nameCXHL2300850 | Fujian Yi Ke University romanized |
| 2023/08/01Import · Class 1 | 注射用佐妥昔单抗 · No verified English nameJXSS2300066 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
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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