YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 321 drug applications between 19 November 2025 and 25 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 60 drug names.
2025/11/19 – 2025/11/25
- New acceptances this week
- 321
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 83
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
321filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 72 |
| New drug | 60 |
| Unspecified | 18 |
| Import | 13 |
| Import re-registration | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| TCM | 85 |
| Therapeutic biologic | 49 |
| Biologic | 11 |
| Prophylactic biologic | 4 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lisdexamfetamine Dimesylate capsules | 4 | 1 | 4 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 3 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 4 | Folic Acid Tablets | 2 | 1 | 12 |
| 5 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Glycerol Fructose And Sodium Chloride Injection | 2 | 1 | 3 |
| 10 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 1 | 1 | 7 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 8 | 7 | 2 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 4 | Novartis Pharma AG | 5 | 4 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Topfond Pharmaceutical Co., Ltd. | 4 | 4 | 0 |
| 8 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Terumo Corporation Kofu Factory | 4 | 1 | 0 |
| 10 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 1 | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/25Import · Class 1 | 注射用Abelacimab · No verified English nameJXSL2500227 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/25Import · Class 1 | PIT565 · No verified English nameJXSL2500226 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/11/25Import · Class 1 | E6742 · No verified English nameJXHL2500363 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/25Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2504063 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2025/11/25Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504056 | Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/11/25Generic · Class 3 | Colchicine TabletsCYHS2504054 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized |
| 2025/11/25Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504051 | Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/11/25New drug · Class 1.1 | 清瘟止咳颗粒 · No verified English nameCXZL2500119 | Jiangxi Bao Zhong Pharmaceutical Co., Ltd. romanized |
| 2025/11/25New drug · Class 2.3 | 女珍颗粒 · No verified English nameCXZL2500118 | Shandong Feng Huang Pharmaceutical Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | 注射用ASKG915 · No verified English nameCXSL2501005 | Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/25New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2501004 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/25New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2501003 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | GKL-006注射液 · No verified English nameCXSL2501002 | Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | VC005片 · No verified English nameCXHL2501293 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2501292 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2501291 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/25New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2501290 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/24Import · Class 1 | 注射用IPN10200 · No verified English nameJXSL2500225 | Ipsen Innovation; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd |
| 2025/11/24Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504045 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/11/24Generic · Class 3 | Folic Acid TabletsCYHS2504044 | Beijing Foyou Pharma CO.,LTD |
| 2025/11/24Generic · Class 3 | Folic Acid TabletsCYHS2504043 | Beijing Foyou Pharma CO.,LTD |
| 2025/11/24New drug · Class 1 | EP-0210单抗注射液 · No verified English nameCXSL2501001 | Chengdu You Luo Bio Technology Co., Ltd. romanized |
| 2025/11/24New drug · Class 1 | R01注射液 · No verified English nameCXSL2501000 | Hangzhou Niu An Jin Bio Technology Co., Ltd. romanized |
| 2025/11/22Import · Class 1 | Itepekimab注射液 · No verified English nameJXSL2500224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500362 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500361 | Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500360 | Cytokinetics, Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/11/22Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2504037 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hui Cheng Pharma Co., Ltd. romanized |
| 2025/11/22Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2504035 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/11/22New drug · Class 3.4 | 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2500125 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized; Nanjing Peng Bo Bio Technology Co., Ltd. romanized |
64 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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