YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 409 drug applications between 14 June 2025 and 20 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 85 drug names.
2025/06/14 – 2025/06/20
- New acceptances this week
- 409
- Drugs with new generic filings (by drug name, de-duplicated)
- 85
- Accepted this week, now under review
- 71
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
409filings, 115 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 115 |
| New drug | 53 |
| Import | 37 |
| Unspecified | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 250 |
| TCM | 85 |
| Therapeutic biologic | 67 |
| Biologic | 4 |
| 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
85 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 4 | 4 | 53 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 3 | Sodium Nitroprusside Injection | 3 | 3 | 15 |
| 4 | Ethyl Iosapentate Capsules | 3 | 2 | 27 |
| 5 | Tadalafil Tablets | 3 | 1 | 23 |
| 6 | Escitalopram Oxalate Tablets | 3 | 1 | 6 |
| 7 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 8 | Bromfenac Sodium Eye Drops | 2 | 2 | 7 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | Polyvinyl Alcohol Eye Drops | 2 | 2 | 24 |
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
248 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Ying Feng Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Amgen Inc. | 8 | 2 | 0 |
| 3 | Novo Nordisk A/S | 8 | 2 | 0 |
| 4 | Pfizer Inc. | 7 | 4 | 0 |
| 5 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 5 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 4 |
| 7 | Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Yunnan Jin Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 5 | 3 | 5 |
| 10 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/20Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502228 | Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/06/20Generic · Class 3 | Benzbromarone TabletsCYHS2502226 | Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized |
| 2025/06/20Generic · Class 3 | 氨基酸(15)腹膜透析液 · No verified English nameCYHS2502220 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/06/20Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHS2502219 | Run Sheng Pharma Co., Ltd. romanized |
| 2025/06/20Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2502216 | Fu Yuan Pharma Co., Ltd. romanized |
| 2025/06/20Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502213 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/06/20New drug · Class 1 | CM336注射液 · No verified English nameCXSL2500503 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | 多抗原自体免疫细胞注射液 · No verified English nameCXSL2500501 | Heng Rui Yuan Zheng (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | 磷酸泊沃昔替尼片 · No verified English nameCXHL2500599 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | 磷酸泊沃昔替尼片 · No verified English nameCXHL2500598 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | 磷酸泊沃昔替尼片 · No verified English nameCXHL2500597 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | BAY 3713372 片 · No verified English nameCXHL2500596 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | BAY 3713372 片 · No verified English nameCXHL2500595 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2025/06/20New drug · Class 2.2; 2.4 | FCZR · No verified English nameCXHL2500594 | Bo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 2.2; 2.4 | FCZR · No verified English nameCXHL2500593 | Bo Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/20New drug · Class 1 | YH004胶囊 · No verified English nameCXHL2500592 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/19Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHS2500073 | DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd |
| 2025/06/19Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHS2500072 | DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd |
| 2025/06/19Import · Class 2.4 | 紫杉醇口服溶液 · No verified English nameJXHS2500071 | DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd |
| 2025/06/19Import · Class 1 | Centanafadine持释胶囊 · No verified English nameJXHL2500152 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2025/06/19Import · Class 1 | Centanafadine持释胶囊 · No verified English nameJXHL2500151 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2025/06/19Import · Class 1 | Centanafadine持释胶囊 · No verified English nameJXHL2500150 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2025/06/19Generic · Class 3 | Foscarnet Sodium InjectionCYHS2502204 | Hainan Ru Kang Bio Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/06/19New drug · Class 3.3 | SYS6036注射液 · No verified English nameCXSL2500500 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/06/19New drug · Class 1 | HX001注射液 · No verified English nameCXSL2500499 | Wuhan Hou Xian Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/19New drug · Class 1 | 丁二酸复瑞替尼胶囊 · No verified English nameCXHL2500591 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2025/06/19New drug · Class 2.2 | 雷美替胺双释片 · No verified English nameCXHL2500590 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/18Import · Class 2.2 | DS-1062a · No verified English nameJXSL2500102 | Daiichi Sankyo Inc. |
| 2025/06/18Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2500101 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/06/18Import · Class 2.2 | 比奇珠单抗注射液 · No verified English nameJXSL2500100 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
92 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.