YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 384 drug applications between 17 December 2025 and 23 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 47 drug names.
2025/12/17 – 2025/12/23
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 80
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
384filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 199 |
| New drug | 90 |
| Generic | 71 |
| Unspecified | 10 |
| Import | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 193 |
| TCM | 125 |
| Therapeutic biologic | 58 |
| Biologic | 5 |
| 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Loxoprofen Sodium Patches | 4 | 2 | 30 |
| 2 | Baricitinib Tablets | 3 | 2 | 32 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 7 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 1 | 11 |
| 8 | Colistimethate Sodium for Injection | 2 | 2 | 2 |
| 9 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 10 | Divalproex Sodium 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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 46 | 39 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 11 | 11 | 0 |
| 3 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 10 | 2 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 8 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 7 | Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized | 5 | 3 | 0 |
| 8 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Name not romanized | 5 | 2 | 0 |
| 10 | Beijing Lian Er Tang 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/23Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2500245 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/12/23Generic · Class 3 | Haloperidol Oral SolutionCYHS2504360 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/12/23Generic · Class 3 | Paracetamol And Ibuprofen Oral SuspensionCYHS2504357 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/12/23Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2500228 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2025/12/23Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500227 | Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/12/23Generic · Class 3 | 氟[18F]妥西吡注射液 · No verified English nameCYHL2500226 | Hangzhou Yi Li Pharmaceuticals Co., Ltd. romanized |
| 2025/12/23New drug · Class 3.3 | QL2109注射液 · No verified English nameCXSL2501120 | Qilu Pharmaceutical Co., Ltd. |
| 2025/12/23New drug · Class 1 | JWK001注射液 · No verified English nameCXSL2501116 | Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501115 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501114 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501113 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501112 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501111 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | GK01活菌散 · No verified English nameCXSL2501110 | Zhejiang Mai Ya Ta Jun Jian Zhi Neng Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 3.2 | 皮下注射人免疫球蛋白 · No verified English nameCXSL2501109 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | GC801注射液 · No verified English nameCXSL2501108 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | RX608片 · No verified English nameCXHL2501445 | Suzhou Run Xin Bio Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | RX608片 · No verified English nameCXHL2501444 | Suzhou Run Xin Bio Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | VG081821AC片 · No verified English nameCXHL2501443 | Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | VG081821AC片 · No verified English nameCXHL2501442 | Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | VG081821AC片 · No verified English nameCXHL2501441 | Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | D3S-002片 · No verified English nameCXHL2501440 | Name not romanized |
| 2025/12/23New drug · Class 1 | D3S-002片 · No verified English nameCXHL2501439 | Name not romanized |
| 2025/12/23New drug · Class 1 | D3S-002片 · No verified English nameCXHL2501438 | Name not romanized |
| 2025/12/23New drug · Class 2.4 | Regadenoson InjectionCXHL2501437 | Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | D3S-002片 · No verified English nameCXHL2501436 | Name not romanized |
| 2025/12/23New drug · Class 1 | D3S-001胶囊 · No verified English nameCXHL2501435 | Name not romanized |
| 2025/12/23New drug · Class 1 | BL0020注射液 · No verified English nameCXHL2501434 | Shanghai Bi Ling Bio Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | INT-210胶囊 · No verified English nameCXHL2501433 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | INT-210胶囊 · No verified English nameCXHL2501432 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
87 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.