YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 317 drug applications between 13 September 2024 and 19 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.
2024/09/13 – 2024/09/19
- New acceptances this week
- 317
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 6
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
317filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 77 |
| New drug | 64 |
| Import | 15 |
| Import re-registration | 5 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 220 |
| TCM | 50 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 8 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 6 | 2 | 31 |
| 2 | Minoxidil Liniment | 4 | 2 | 52 |
| 3 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 4 | Alanyl Glutamine Injection | 2 | 1 | 4 |
| 5 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 6 | Pregabalin Orally Disintegrating Tablets | 2 | 1 | 3 |
| 7 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 8 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 9 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 10 | 氯化钙注射液 · No verified English name | 2 | 1 | 6 |
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
172 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 35 | 35 | 0 |
| 2 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 10 | 3 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 9 | 4 | 1 |
| 4 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | AstraZeneca AB | 5 | 4 | 0 |
| 6 | Pfizer Europe MA EEIG | 5 | 3 | 0 |
| 7 | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 5 |
| 8 | Hua Ren Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 4 | 4 | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/19Import · Class 1 | Volixibat胶囊 · No verified English nameJXHL2400220 | Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2024/09/19Import · Class 1 | Volixibat胶囊 · No verified English nameJXHL2400219 | Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2024/09/19Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2403122 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/09/19Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2403117 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/09/19Generic · Class 3 | Sulindac TabletsCYHS2403116 | Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized |
| 2024/09/19Generic · Class 3 | Sulindac TabletsCYHS2403115 | Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized |
| 2024/09/19Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2403113 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2024/09/19Generic · Class 3 | Relugolix TabletsCYHL2400191 | Qilu Pharmaceutical Co., Ltd. |
| 2024/09/19Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHL2400190 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized |
| 2024/09/19Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400189 | Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized |
| 2024/09/19New drug · Class 3.1 | 桃红四物颗粒 · No verified English nameCXZS2400031 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized |
| 2024/09/19New drug · Class 1.1 | 十味疏风颗粒 · No verified English nameCXZL2400055 | Shandong Sheng Yao Xue Ke College romanized; Hangzhou Yuan Cao Pharma Co., Ltd. romanized |
| 2024/09/19New drug · Class 2.3 | 黄蛭益肾胶囊 · No verified English nameCXZL2400054 | Lei Yun Shang Pharma Group Co., Ltd. romanized |
| 2024/09/19New drug · Class 1.1 | 四仙颗粒 · No verified English nameCXZL2400053 | Sichuan Sheng Zhong Pharmaceuticals Ke College romanized |
| 2024/09/19New drug · Class 3.3 | 流感病毒亚单位疫苗 · No verified English nameCXSS2400100 | Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | MC-1-50细胞制剂 · No verified English nameCXSL2400632 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | MWN105注射液 · No verified English nameCXSL2400631 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | IMM0306 · No verified English nameCXSL2400630 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/09/19New drug · Class 2.2 | 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400629 | Ai Mei Cheng Xin Biopharmaceutical Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | TDM-180935软膏 · No verified English nameCXHL2400985 | Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | TDM-180935软膏 · No verified English nameCXHL2400984 | Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | TDM-180935软膏 · No verified English nameCXHL2400983 | Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized |
| 2024/09/19New drug · Class 1 | 注射用苯磺酸CG-0255 · No verified English nameCXHL2400982 | Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/19New drug · Class 2.3 | SMF-211 · No verified English nameCXHL2400981 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/09/19New drug · Class 2.4 | 利马前列素片 · No verified English nameCXHL2400980 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2024/09/18New drug · Class 1 | 注射用BG-T187 · No verified English nameCXSL2400628 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/09/18New drug · Class 1 | 奥美克松钠注射液 · No verified English nameCXHS2400096 | Hangzhou Ao Mo Pharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2024/09/18New drug · Class 1 | CTS3497胶囊 · No verified English nameCXHL2400979 | Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/18New drug · Class 1 | CTS3497胶囊 · No verified English nameCXHL2400978 | Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/18New drug · Class 1 | HRS-3802缓释片 · No verified English nameCXHL2400977 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
79 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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