YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 243 drug applications between 29 June 2021 and 5 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 27 drug names.
2021/06/29 – 2021/07/05
- New acceptances this week
- 243
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- Accepted this week, now under review
- 0
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
243filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| New drug | 39 |
| Generic | 37 |
| Import | 25 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 163 |
| Therapeutic biologic | 41 |
| TCM | 32 |
| Prophylactic biologic | 7 |
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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 7 | 3 | 23 |
| 2 | Clindamycin Injection | 2 | 1 | 4 |
| 3 | Lidocaine Hydrochloride Injection | 2 | 1 | 6 |
| 4 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 5 | Febuxostat Tablets | 2 | 1 | 12 |
| 6 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 1 | 1 | 0 |
| 7 | Risperidone Oral Solution | 1 | 1 | 6 |
| 8 | Compound Ipratropium Bromide Solution For Inhalation | 1 | 1 | 4 |
| 9 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 1 | 2 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
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
136 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Roche Pharma (Schweiz) Ltd. | 6 | 1 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Merck Sharp & Dohme Corp. | 4 | 2 | 0 |
| 9 | Novo Nordisk A/S | 4 | 2 | 0 |
| 10 | GlaxoSmithKline Biologicals SA | 4 | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101116 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101115 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101114 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101113 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101112 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101111 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101110 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | Belzutifan片 · No verified English nameJXHL2101109 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd. |
| 2021/07/05Generic · Class 3 | Mesalamine extended release capsulesCYHS2101385 | Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2021/07/05Generic · Class 3 | Pregabalin Extended release TabletsCYHL2101017 | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized |
| 2021/07/05New drug · Class 1.1 | 脑脉通颗粒 · No verified English nameCXZL2101016 | Guangdong Yao Ke University romanized |
| 2021/07/05New drug · Class 1 | 普特利单抗注射液 · No verified English nameCXSS2101008 | Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | 注射用QLF31907 · No verified English nameCXSL2101171 | Qilu Pharmaceutical Co., Ltd. |
| 2021/07/05New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2101170 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | 注射用BJ-005 · No verified English nameCXSL2101168 | Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | HS-10241片 · No verified English nameCXHL2101262 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | HS-10241片 · No verified English nameCXHL2101261 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/05New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHL2101260 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/05New drug · Class 2.4 | Lenvatinib Mesilate CapsulesCXHL2101259 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101253 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101252 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | JYP0061片 · No verified English nameCXHL2101251 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/02Import · Class 3.1 | 莫格利珠单抗注射液 · No verified English nameJXSS2101015 | Kyowa Kirin Co. Ltd.; Toyobo Company Limited Otsu Pharmaceutical Plant |
| 2021/07/02Import · Class 2.2 | DS-8201a · No verified English nameJXSL2101064 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/07/02Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101063 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/07/02Import · Class 1 | RO7247669注射液 · No verified English nameJXSL2101059 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd |
| 2021/07/02Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2101380 | Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/07/02Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2101379 | Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/07/02New drug · Class 1.2 | 广金钱草总黄酮胶囊 · No verified English nameCXZS2101003 | Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | EP-9001A注射液 · No verified English nameCXSL2101166 | Chengdu You Luo Bio Technology Co., Ltd. romanized |
44 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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