YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 334 drug applications between 15 June 2025 and 21 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 75 drug names.
2025/06/15 – 2025/06/21
- New acceptances this week
- 334
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 63
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
334filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 107 |
| New drug | 43 |
| Import | 34 |
| Unspecified | 4 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 72 |
| Therapeutic biologic | 65 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 6 | 6 | 53 |
| 2 | Ethyl Iosapentate Capsules | 4 | 3 | 27 |
| 3 | 注射用甲苯磺酸奥马环素 · No verified English name | 3 | 3 | 9 |
| 4 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 5 | Sodium Nitroprusside Injection | 3 | 3 | 15 |
| 6 | Tadalafil Tablets | 3 | 1 | 23 |
| 7 | Escitalopram Oxalate Tablets | 3 | 1 | 6 |
| 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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 14 | 2 | 0 |
| 2 | Novo Nordisk A/S | 8 | 2 | 0 |
| 3 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 5 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 4 |
| 5 | Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Yunnan Jin Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Pfizer Inc. | 5 | 3 | 0 |
| 8 | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 5 | 3 | 5 |
| 9 | Wen Zhou Hai He Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 4 | 2 | 4 |
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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500109 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500108 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500107 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500106 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500105 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133 · No verified English nameJXSL2500104 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AZD8205 · No verified English nameJXSL2500103 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/06/21Generic · Class 3 | 小儿多种维生素注射液(13) · No verified English nameCYHS2502241 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2025/06/21Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2502229 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/06/21Generic · Class 3 | Elagolix TabletsCYHL2500118 | Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2025/06/21Generic · Class 3 | Elagolix TabletsCYHL2500117 | Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2025/06/21Generic · Class 3 | Levothyroxine Sodium Oral SolutionCYHL2500116 | Jiangsu Bei Mei Pharmaceutical Co., Ltd. romanized |
| 2025/06/21New drug · Class 1 | T3011疱疹病毒注射液 · No verified English nameCXSL2500502 | Suzhou Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/21New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2500603 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2025/06/21New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2500602 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2025/06/21New drug · Class 1 | HSK47388片 · No verified English nameCXHL2500601 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/06/21New drug · Class 1 | HSK47388片 · No verified English nameCXHL2500600 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 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 |
78 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.