YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 20 November 2025 and 26 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 61 drug names.
2025/11/20 – 2025/11/26
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- 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
323filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 73 |
| New drug | 58 |
| Unspecified | 19 |
| Import | 13 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 96 |
| Therapeutic biologic | 46 |
| Biologic | 11 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 2 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 3 | 氢溴酸加兰他敏口崩片 · No verified English name | 3 | 1 | 3 |
| 4 | Tacrolimus Ointment | 2 | 1 | 6 |
| 5 | Folic Acid Tablets | 2 | 1 | 12 |
| 6 | Empagliflozin Tablets | 2 | 1 | 18 |
| 7 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 8 | 氯雷他定糖浆 · No verified English name | 2 | 1 | 7 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 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
203 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 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Guangdong Lei Yun Shang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Novartis Pharma AG | 5 | 4 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 4 | 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 | Jiangxi Qing Chun Kang Yuan Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 4 | 2 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/26Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2500139 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/11/26Generic · Class 3 | 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504070 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2025/11/26Generic · Class 3 | 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504069 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2025/11/26Generic · Class 3 | 氢溴酸加兰他敏口崩片 · No verified English nameCYHS2504068 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2025/11/26Generic · Class 3 | Flurbiprofen PatchesCYHL2500209 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | IBI3013 · No verified English nameCXSL2501010 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | IBI3013 · No verified English nameCXSL2501009 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/26New drug · Class 3.4 | 人凝血因子Ⅸ · No verified English nameCXSL2501008 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | 注射用HBT-708 · No verified English nameCXSL2501007 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | 注射用HBT-708 · No verified English nameCXSL2501006 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/26New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHS2500143 | Bei Da Pharma Co., Ltd. romanized |
| 2025/11/26New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHS2500142 | Bei Da Pharma Co., Ltd. romanized |
| 2025/11/26New drug · Class 2.2 | SBK014干混悬剂 · No verified English nameCXHL2501296 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | ZB-002片 · No verified English nameCXHL2501295 | Guizhou Yi Ke University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/26New drug · Class 1 | ZB-002片 · No verified English nameCXHL2501294 | Guizhou Yi Ke University romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Shan Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhi Ben Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
55 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.