YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 435 drug applications between 5 July 2025 and 11 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 76 drug names.
2025/07/05 – 2025/07/11
- New acceptances this week
- 435
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 98
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
435filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 108 |
| New drug | 91 |
| Import | 26 |
| Import re-registration | 12 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 300 |
| Therapeutic biologic | 68 |
| TCM | 63 |
| Biologic | 2 |
| 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 4 | 4 | 53 |
| 2 | Empagliflozin Tablets | 4 | 2 | 18 |
| 3 | Quetiapine Fumarate Extended-release Tablets | 4 | 1 | 0 |
| 4 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 5 | Acyclovir Tablets | 3 | 1 | 6 |
| 6 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 7 | Bilastine Oral Solution | 2 | 2 | 8 |
| 8 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 9 | 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name | 2 | 2 | 2 |
| 10 | Finerenone Tablets | 2 | 2 | 69 |
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
259 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 18 | 15 | 0 |
| 2 | Eli Lilly and Company | 10 | 3 | 0 |
| 3 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Celgene Corporation | 6 | 1 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Topfond Pharmaceutical Co., Ltd. | 5 | 5 | 0 |
| 9 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Karuna Therapeutics Inc. | 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
148 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/11Import · Class 2.2 | 替利珠单抗注射液 · No verified English nameJXSL2500120 | Sanofi-Aventis Recherche & Développement |
| 2025/07/11Import · Class 1 | RO7435846片 · No verified English nameJXHL2500178 | F. Hoffmann-La Roche Ltd |
| 2025/07/11Import · Class 1 | RO7435846片 · No verified English nameJXHL2500177 | F. Hoffmann-La Roche Ltd |
| 2025/07/11Import · Class 1 | RO7435846片 · No verified English nameJXHL2500176 | F. Hoffmann-La Roche Ltd |
| 2025/07/11Import · Class 1 | RO7435846片 · No verified English nameJXHL2500175 | F. Hoffmann-La Roche Ltd |
| 2025/07/11Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2502482 | Beijing Foyou Pharma CO.,LTD |
| 2025/07/11Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2502481 | Beijing Foyou Pharma CO.,LTD |
| 2025/07/11Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2502475 | Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2502474 | Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2502473 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2502472 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2502471 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2502470 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/07/11Generic · Class 3 | Bilastine Oral SolutionCYHS2502467 | Zhuhai Bei Shan Bio Technology Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | 注射用SHR-1802 · No verified English nameCXSL2500572 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | 匹康奇拜单抗注射液 · No verified English nameCXSL2500571 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | 匹康奇拜单抗注射液 · No verified English nameCXSL2500570 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | GR2301注射液 · No verified English nameCXSL2500569 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/11New drug · Class 2.2 | 多西他赛注射用浓溶液(自乳化型) · No verified English nameCXHS2500079 | Beijing De Li Ying Jie Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/07/11New drug · Class 1 | GFH375片 · No verified English nameCXHL2500685 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2500684 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2500683 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2500682 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | CA111注射液 · No verified English nameCXHL2500678 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | CA111注射液 · No verified English nameCXHL2500677 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | BIOS-0623-Z4片 · No verified English nameCXHL2500676 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | BIOS-0623-Z4片 · No verified English nameCXHL2500675 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/11New drug · Class 1 | LXH-1211片 · No verified English nameCXHL2500674 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2025/07/11New drug · Class 1 | LXH-1211片 · No verified English nameCXHL2500673 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2025/07/11New drug · Class 1 | LXH-1211片 · No verified English nameCXHL2500672 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
118 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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